Motrin 600mg Tablets

Manufacturer PFIZER 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)
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Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
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Pregnancy Category
Category C (first and second trimesters); Category D (third trimester)
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FDA Approved
May 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ibuprofen is a medicine called an NSAID, which stands for Non-Steroidal Anti-Inflammatory Drug. It works by reducing substances in the body that cause pain, fever, and inflammation (swelling and redness). It's commonly used to relieve pain from headaches, menstrual cramps, muscle aches, arthritis, and to reduce fever.
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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. If it causes stomach upset, take it with food to help minimize discomfort. Always take the medication with a full glass of water.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry location, avoiding the bathroom. Protect it from heat sources. Store all medications in a safe place, out of the 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, consult your pharmacist for guidance on proper disposal. You may also have access to local drug take-back programs.

What to Do If You Miss 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Avoid alcohol while taking ibuprofen, as it can increase the risk of stomach bleeding.
  • Do not take more than the recommended dose or for longer than advised by your doctor, due to potential serious side effects.
  • Stay hydrated, especially if you have kidney problems or are taking diuretics.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg orally every 6-8 hours as needed
Dose Range: 400 - 800 mg

Condition-Specific Dosing:

mild-moderate pain: 400 mg orally every 4-6 hours as needed
rheumatoid arthritis/osteoarthritis: 400-800 mg orally 3-4 times daily (max 3200 mg/day)
fever: 200-400 mg orally every 4-6 hours as needed
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for 600mg strength; lower strengths (e.g., drops) are used for fever/pain (5-10 mg/kg/dose every 6-8 hours)
Child: Not established for 600mg strength; lower strengths (e.g., suspension) are used for fever/pain (5-10 mg/kg/dose every 6-8 hours, max 40 mg/kg/day)
Adolescent: For pain/fever: 400 mg orally every 4-6 hours as needed. For juvenile idiopathic arthritis: 30-50 mg/kg/day in 3-4 divided doses (max 2400 mg/day).
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Avoid if possible; if necessary, use lowest effective dose and monitor closely. Consider dose reduction.
Severe: Contraindicated in advanced renal disease.
Dialysis: Ibuprofen is not significantly removed by hemodialysis. Avoid use due to risk of renal toxicity.

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 altered drug clearance.

Pharmacology

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Mechanism of Action

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) that exerts its analgesic, anti-inflammatory, and antipyretic effects primarily through the reversible inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever.
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Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 1-2 hours (oral)
FoodEffect: Food may decrease the rate but not the extent of absorption, potentially delaying Tmax.

Distribution:

Vd: 0.12-0.18 L/kg
ProteinBinding: Approximately 99% (primarily to albumin)
CnssPenetration: Limited (low concentrations in CSF, but sufficient for central antipyretic effect)

Elimination:

HalfLife: 1.8-2.5 hours
Clearance: Approximately 0.05-0.1 L/hr/kg
ExcretionRoute: Renal (approximately 60-90% as metabolites and their conjugates, 1% as unchanged drug)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (analgesic/antipyretic)
PeakEffect: 1-2 hours (analgesic/antipyretic); several days to weeks for full anti-inflammatory effect in chronic conditions.
DurationOfAction: 4-6 hours (analgesic/antipyretic)

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 immediate medical attention:

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, difficulty 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 or 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: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or 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 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. These reactions can be life-threatening and may also affect internal organs. Seek immediate medical help if you experience:

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. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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)
  • Chest pain, shortness of breath, sudden weakness on one side of the body, or slurred speech (signs of heart attack or stroke)
  • Swelling in your ankles, feet, or hands, or decreased urination (signs of kidney problems)
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Unexplained weight gain or swelling
  • 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 drugs, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (a weak heart)
+ Recent heart attack
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Fertility issues or ongoing fertility evaluation, as this medication may affect pregnancy.
* Pregnancy or plans to become pregnant. This medication can harm an unborn baby if taken after 20 weeks of pregnancy. 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 for an extended period, 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 about the potential risks. Individuals with asthma should also talk to their doctor, as they may be more sensitive to this medication.

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

Be cautious, as this medication may affect your blood's ability to clot, making you more prone to bleeding. To minimize the risk of injury, use a soft toothbrush and an electric razor.

The use of this medication may increase the risk of heart failure, particularly in individuals with pre-existing heart failure. This can lead to a higher chance of heart attack, hospitalization, and death. Discuss these risks with your doctor. Additionally, people who have recently experienced a heart attack may have a higher risk of heart attack and heart-related death when taking this medication. Your doctor can provide more information on this topic.

There is also a risk of developing aseptic meningitis, a severe brain problem, associated with this medication. Seek immediate medical attention if you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.

In rare cases, this medication can cause liver problems, which can be life-threatening. If you notice any signs of liver problems, such as dark urine, fatigue, loss of appetite, stomach pain or nausea, pale stools, vomiting, or yellowing of the skin or eyes, 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 the potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea, vomiting, abdominal pain
  • Drowsiness, dizziness, headache
  • Tinnitus (ringing in ears)
  • Nystagmus (involuntary eye movement)
  • Metabolic acidosis
  • Renal failure
  • Coma, seizures (in severe cases)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve gastric lavage, activated charcoal, and supportive care.

Drug Interactions

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Contraindicated Interactions

  • Aspirin (high-dose, for antiplatelet effect, due to interference)
  • Other NSAIDs (increased risk of GI and renal adverse effects)
  • Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Clopidogrel, Aspirin low-dose): Increased risk of bleeding.
  • Corticosteroids: Increased risk of GI ulceration/bleeding.
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced diuretic and antihypertensive effect, increased risk of renal impairment.
  • ACE Inhibitors/ARBs (e.g., Lisinopril, Valsartan): Reduced antihypertensive effect, increased risk of renal impairment and hyperkalemia.
  • Lithium: Increased lithium plasma concentrations and toxicity.
  • Methotrexate: Increased methotrexate plasma concentrations and toxicity.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
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Moderate Interactions

  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • Digoxin: May increase digoxin plasma concentrations.
  • Phenytoin: May increase phenytoin plasma concentrations.
  • Sulfonylureas: May enhance hypoglycemic effect.
  • Aminoglycosides: May increase aminoglycoside levels (via reduced renal clearance).
  • Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid concomitant use in patients with renal impairment).
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Minor Interactions

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

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline for potential hematologic adverse effects (e.g., anemia, thrombocytopenia) with long-term use.

Timing: Before initiating long-term therapy.

Renal Function (BUN, Creatinine, eGFR)

Rationale: To assess baseline kidney function, as NSAIDs can cause renal impairment.

Timing: Before initiating therapy, especially in patients with pre-existing renal impairment or risk factors.

Liver Function Tests (ALT, AST, Bilirubin)

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

Timing: Before initiating therapy, especially in patients with pre-existing hepatic impairment.

Blood Pressure

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

Timing: Before initiating therapy.

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Routine Monitoring

Renal Function (BUN, Creatinine, eGFR)

Frequency: Periodically (e.g., every 6-12 months) for long-term therapy, or more frequently in high-risk patients (elderly, heart failure, diuretic use).

Target: Within normal limits; monitor for increases.

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 for long-term therapy (e.g., every 6-12 months).

Target: Within normal limits; monitor for elevations.

Action Threshold: Elevations >3 times upper limit of normal; consider discontinuation.

Blood Pressure

Frequency: Regularly, especially in hypertensive patients.

Target: Individualized; maintain within target range.

Action Threshold: Sustained increase in blood pressure; consider antihypertensive adjustment or NSAID discontinuation.

Complete Blood Count (CBC)

Frequency: Periodically for long-term therapy (e.g., annually).

Target: Within normal limits.

Action Threshold: Significant decrease in hemoglobin/hematocrit or platelet count; investigate for GI bleeding or other hematologic issues.

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Symptom Monitoring

  • Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
  • Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
  • Signs of renal impairment (decreased urine output, swelling in ankles/feet, unusual fatigue)
  • Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
  • Signs of allergic reaction (rash, itching, swelling of face/throat, difficulty breathing)
  • Unusual bruising or bleeding

Special Patient Groups

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Pregnancy

Ibuprofen should be avoided during pregnancy, especially in the third trimester, due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use in the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest duration.

Trimester-Specific Risks:

First Trimester: Possible increased risk of miscarriage and congenital malformations (e.g., cardiac septal defects, gastroschisis), though evidence is conflicting and less robust than for later trimesters.
Second Trimester: Generally considered safer than the third trimester, but still carries risks. Use with caution and only if clearly needed.
Third Trimester: High risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios (due to fetal renal dysfunction), and inhibition of labor. Contraindicated.
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Lactation

Ibuprofen is 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 (L3 - Moderately safe; minimal non-serious adverse effects reported in some infants, but generally considered safe).
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Pediatric Use

Ibuprofen is widely used in pediatric populations for fever and pain, but the 600mg strength is typically not used in young children. Dosing is weight-based (5-10 mg/kg/dose). Caution is advised in dehydrated children due to increased risk of renal adverse effects. Always use appropriate pediatric formulations (suspension, drops) and dosing guidelines.

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Geriatric Use

Elderly patients are at increased risk for serious adverse effects of NSAIDs, including gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration. Monitor renal function, blood pressure, and for 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 GI upset.
  • Educate patients about the signs and symptoms of GI bleeding and cardiovascular events, and when to seek immediate medical attention.
  • Remind patients that ibuprofen is available over-the-counter in lower strengths (e.g., 200mg), and they should not combine prescription strength with OTC products without medical advice.
  • For chronic use, consider co-prescribing a proton pump inhibitor (PPI) or H2 blocker for GI protection, especially in high-risk patients.
  • Counsel patients on the importance of hydration to help protect kidney function, especially when taking NSAIDs.
  • Ibuprofen can interfere with the antiplatelet effect of low-dose aspirin. If both are necessary, ibuprofen should be taken at least 30 minutes after or 8 hours before immediate-release aspirin.
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Alternative Therapies

  • Acetaminophen (Tylenol - for pain/fever, no anti-inflammatory effect, different side effect profile)
  • Other NSAIDs (e.g., Naproxen, Celecoxib, Diclofenac - different half-lives, COX selectivity, and side effect profiles)
  • Opioid analgesics (for severe pain, with higher risk of dependence and side effects)
  • Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches - for localized pain)
  • Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, massage, acupuncture, heat/cold therapy)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (600mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand) for most insurance plans.
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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 provides crucial information for patients. Please read this guide 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 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 details about the medication taken, the quantity, and the time it occurred.