The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
(in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Otc - Purpose
Nighttime sleep aid
Indications & Usage
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
- WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- More than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
- Do not usewith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.with any other product containing diphenhydramine, even one used on skinin children under 12 years of ageif you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
- Ask a doctor before use if you haveliver diseasea breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandglaucoma
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarintaking sedatives or tranquilizers
Otc - When Using
- When using this productdrowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinery
Otc - Stop Use
- Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.pain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
- Directionsdo not take more than directed (see overdose warning)adults and children 12 years and over:take 2 caplets at bedtimedo not take more than 2 caplets of this product in 24 hours.children under 12 years: do not use
- Other informationstore between 20-25°C (68-77°F)
Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide
**may contain this ingredient
Otc - Questions
Questions or comments? call
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