Ibuprofen 200mg Tablets

Manufacturer MAJOR PHARMACEUTICALS Active Ingredient Ibuprofen Tablets(eye byoo PROE fen) Pronunciation eye-byoo-PROE-fen
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to ease pain, swelling, and fever.It is used to ease painful period (menstrual) cycles.It is used to treat arthritis.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Analgesic, Antipyretic
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Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
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Pregnancy Category
Category C (1st & 2nd Trimester), Category D (3rd Trimester)
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ibuprofen is a common medicine used to relieve pain, reduce fever, and lessen inflammation (swelling and redness). It belongs to a group of medicines called NSAIDs. It works by blocking certain natural substances in your body that cause pain and inflammation.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Always take it with a full glass of water.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Protect it from heat and keep it out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at once or extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Drink plenty of fluids to help protect your kidneys.
  • Avoid or limit alcohol consumption while taking ibuprofen, as it can increase the risk of stomach bleeding.
  • Do not take more than the recommended dose or for longer than directed without consulting a doctor.
  • Inform your doctor or dentist that you are taking ibuprofen before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: 200 mg to 400 mg orally every 4 to 6 hours as needed
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

OTC Maximum: 1200 mg in 24 hours
Prescription Maximum: 3200 mg in 24 hours (divided doses)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for OTC use under 6 months; consult physician for prescription use (e.g., patent ductus arteriosus)
Child: 5-10 mg/kg/dose orally every 6-8 hours as needed for fever/pain (max 40 mg/kg/day). For OTC, typically 6 months to 11 years, follow package directions based on age/weight.
Adolescent: 200-400 mg orally every 4-6 hours as needed (max 1200 mg/day for OTC)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Use with caution; consider dose reduction and monitor renal function closely. Avoid if GFR < 30 mL/min.
Severe: Contraindicated in severe renal impairment (GFR < 30 mL/min) due to risk of acute renal failure.
Dialysis: Not significantly removed by hemodialysis. Avoid use due to underlying renal disease.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; consider dose reduction and monitor liver function closely.
Severe: Avoid use in severe hepatic impairment due to risk of exacerbating liver dysfunction and increased systemic exposure.

Pharmacology

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Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects primarily by inhibiting the cyclooxygenase (COX) enzymes, COX-1 and COX-2. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever. By reducing prostaglandin levels, ibuprofen alleviates pain, reduces inflammation, and lowers elevated body temperature.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-100%
Tmax: 1-2 hours (fasted state)
FoodEffect: Food delays the rate of absorption (increases Tmax) but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 0.1-0.2 L/kg
ProteinBinding: >99% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1.8-2.5 hours
Clearance: Not readily available as a single rate, but primarily hepatic metabolism followed by renal excretion.
ExcretionRoute: Renal (approximately 60-90% as metabolites and their conjugates), Fecal (approximately 10% as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for analgesia)
PeakEffect: 1-2 hours (for analgesia)
DurationOfAction: 4-6 hours

Safety & Warnings

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BLACK BOX WARNING

CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs, including ibuprofen, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: NSAIDs, including ibuprofen, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises that enlarge, or uncontrollable bleeding.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden significant weight gain.
Signs of high potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision.
Shortness of breath, sudden significant weight gain, or swelling in the arms or legs.
Chest pain or pressure, or a rapid heartbeat.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Ringing in the ears.
Severe back pain.
Changes in vision.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help immediately:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Gas
Dizziness

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools, or vomit that looks like coffee grounds (signs of stomach bleeding)
  • Swelling of the face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction)
  • Chest pain, weakness on one side of the body, sudden slurred speech (signs of heart attack or stroke)
  • Sudden weight gain, swelling in your hands or feet, or shortness of breath (signs of heart problems or fluid retention)
  • Less frequent urination or dark urine (signs of kidney problems)
  • Yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
  • Severe skin rash, blistering, or peeling
  • Unusual bruising or bleeding
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (a weakened heart)
+ Recent heart attack
Concurrent use of other NSAIDs, salicylate medications like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluations, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or suspected pregnancy. This medication can harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug long-term, your doctor may recommend regular blood tests to monitor your condition.

There is a risk of developing high blood pressure while taking this medication. Your doctor will advise you on how often to have your blood pressure checked. Additionally, discuss your alcohol consumption with your doctor before drinking. If you smoke, consult with your doctor, as smoking may interact with this medication. If you have asthma, talk to your doctor, as you may be more sensitive to this drug.

Adhere to the prescribed dosage and do not exceed the recommended amount, as taking more than directed may increase the risk of severe side effects. Also, do not take this medication for longer than your doctor has prescribed.

Be cautious, as this medication may increase your risk of bleeding easily. To minimize this risk, use a soft toothbrush and an electric razor, and avoid injuries.

The use of this medication may increase the risk of heart failure, heart attack, and death, particularly in people with pre-existing heart failure. Discuss this risk with your doctor. Furthermore, if you have recently experienced a heart attack, the use of this medication may increase the risk of another heart attack or heart-related death. Your doctor will help you weigh the benefits and risks.

This medication may also increase the risk of aseptic meningitis, a severe brain problem. Seek immediate medical attention if you experience symptoms such as headache, fever, chills, severe stomach upset, stiff neck, rash, sensitivity to light, drowsiness, or confusion.

In rare cases, this medication may cause liver problems, which can be life-threatening. Monitor for signs of liver problems, including dark urine, fatigue, decreased appetite, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor promptly.

If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age should be aware that this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns with your doctor.

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe stomach pain
  • Nausea, vomiting
  • Drowsiness, lethargy
  • Dizziness
  • Headache
  • Tinnitus (ringing in ears)
  • Nystagmus (involuntary eye movements)
  • Rarely: metabolic acidosis, coma, acute renal failure, respiratory depression, seizures

What to Do:

Seek immediate medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and symptomatic; may include gastric lavage, activated charcoal, and monitoring of vital signs and renal function.

Drug Interactions

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Contraindicated Interactions

  • Aspirin (high-dose, due to increased risk of GI bleeding and reduced antiplatelet effect of aspirin)
  • Other NSAIDs (increased risk of GI and renal adverse effects)
  • Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain, due to increased risk of MI and stroke)
  • Severe uncontrolled heart failure
  • Severe renal impairment
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
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Major Interactions

  • Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Clopidogrel, Aspirin at antiplatelet doses): Increased risk of GI bleeding.
  • Corticosteroids: Increased risk of GI ulceration and bleeding.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment (especially in dehydrated or elderly patients).
  • Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
  • Methotrexate: Increased methotrexate plasma levels and toxicity (renal clearance reduced).
  • Lithium: Increased lithium plasma levels and toxicity (reduced renal clearance).
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Digoxin: May increase digoxin serum concentrations.
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Moderate Interactions

  • Beta-blockers: Reduced antihypertensive effect.
  • Sulfonylureas: May enhance hypoglycemic effect.
  • Phenytoin: May increase phenytoin serum concentrations.
  • Tacrolimus: Increased risk of nephrotoxicity.
  • Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with CrCl < 80 mL/min).
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Minor Interactions

  • Alcohol: Increased risk of GI irritation/bleeding.
  • Ginkgo Biloba: Theoretical increased risk of bleeding.

Monitoring

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Baseline Monitoring

Renal Function (Serum Creatinine, eGFR)

Rationale: To establish baseline kidney function, especially important before initiating in patients with pre-existing renal impairment or risk factors.

Timing: Prior to initiation, particularly for chronic use or in at-risk patients.

Liver Function Tests (ALT, AST)

Rationale: To establish baseline liver function, as NSAIDs can cause liver enzyme elevations.

Timing: Prior to initiation, especially for chronic use or in patients with pre-existing liver disease.

Complete Blood Count (CBC) with differential

Rationale: To establish baseline hematologic status, as NSAIDs can rarely cause blood dyscrasias or exacerbate anemia due to GI bleeding.

Timing: Prior to initiation for long-term therapy.

Blood Pressure

Rationale: NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.

Timing: Prior to initiation.

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Routine Monitoring

Renal Function (Serum Creatinine, eGFR)

Frequency: Periodically (e.g., every 6-12 months for chronic use, more frequently in at-risk patients or with concomitant nephrotoxic drugs)

Target: Within patient's baseline or normal limits

Action Threshold: Significant increase in creatinine (>20-30% from baseline) or decrease in eGFR; consider dose reduction or discontinuation.

Liver Function Tests (ALT, AST)

Frequency: Periodically (e.g., every 6-12 months for chronic use)

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x upper limit of normal); consider discontinuation.

Blood Pressure

Frequency: Regularly (e.g., at each visit for chronic use)

Target: Within target range for patient's condition

Action Threshold: Sustained elevation; consider antihypertensive adjustment or NSAID discontinuation.

Hemoglobin/Hematocrit

Frequency: Periodically (e.g., annually for chronic use, or if symptoms of anemia/bleeding occur)

Target: Within normal limits

Action Threshold: Significant drop; investigate for GI bleeding.

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Symptom Monitoring

  • Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
  • Signs of fluid retention/edema (swelling in ankles, feet, hands)
  • Unexplained weight gain
  • Shortness of breath or chest pain (signs of cardiovascular events)
  • Skin rash or blistering (severe skin reactions)
  • Unusual bruising or bleeding
  • Changes in urination (decreased urine output)
  • Yellowing of skin or eyes (jaundice), dark urine, unusual fatigue (liver problems)
  • Severe headache, stiff neck, fever, confusion (aseptic meningitis, rare)

Special Patient Groups

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Pregnancy

Ibuprofen should be avoided in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn. Use in the first and second trimesters should be limited to the lowest effective dose for the shortest possible duration, only if clearly needed and the potential benefit outweighs the risk.

Trimester-Specific Risks:

First Trimester: Possible increased risk of miscarriage and congenital malformations (e.g., cardiac defects, gastroschisis), though data are conflicting.
Second Trimester: Generally considered safer than the first or third trimester, but still use with caution and only if clearly indicated. Risk of oligohydramnios (low amniotic fluid) and fetal renal dysfunction with prolonged use.
Third Trimester: Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, and potential for delayed labor.
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Lactation

Ibuprofen is generally considered compatible with breastfeeding. It is excreted into breast milk in very small amounts, and adverse effects in breastfed infants are unlikely.

Infant Risk: Low risk (L2)
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Pediatric Use

For children 6 months and older, use weight-based dosing (5-10 mg/kg/dose). Do not exceed 4 doses in 24 hours. For children under 6 months, consult a physician. Always use the appropriate formulation (e.g., liquid suspension) and measuring device. Avoid in children with dehydration or significant renal impairment.

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Geriatric Use

Elderly patients are at increased risk for serious adverse effects, particularly gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function and signs of GI bleeding closely.

Clinical Information

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Clinical Pearls

  • Always advise patients to take ibuprofen with food, milk, or antacids to minimize gastrointestinal upset.
  • Educate patients on the signs and symptoms of GI bleeding (black, tarry stools; coffee-ground vomit) and to seek immediate medical attention if they occur.
  • Remind patients that ibuprofen is an NSAID and should not be taken with other NSAIDs (including naproxen, celecoxib, or prescription NSAIDs) or high-dose aspirin due to increased risk of adverse effects.
  • Counsel patients on the importance of hydration, especially when taking ibuprofen, to help protect kidney function.
  • For patients with cardiovascular risk factors or pre-existing cardiovascular disease, consider alternative analgesics if possible, or use ibuprofen at the lowest effective dose for the shortest duration.
  • Be aware of the potential for drug interactions, especially with anticoagulants, antiplatelets, ACE inhibitors, ARBs, and diuretics.
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Alternative Therapies

  • Acetaminophen (Tylenol) - for pain and fever, no anti-inflammatory effect, different side effect profile.
  • Naproxen (Aleve) - another NSAID with a longer half-life, allowing for less frequent dosing.
  • Aspirin - for pain, fever, inflammation (at higher doses), and antiplatelet effects (at low doses).
  • Celecoxib (Celebrex) - a selective COX-2 inhibitor, potentially lower GI risk but similar CV risk.
  • Topical analgesics (e.g., diclofenac gel, capsaicin cream) - for localized pain.
  • Non-pharmacological interventions (e.g., RICE therapy for injuries, heat/cold packs, massage, physical therapy).
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (200mg OTC)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.