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 - Purpose
(in each caplet)
PurposeAcetaminophen 500 mgPain relieverDiphenhydramine HCl 25 mgNighttime sleep aid
Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
- This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product
- Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- With 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
Ask A Doctor Before Use If You Have
- Liver diseasea breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandglaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking the blood thinning drug warfarintaking sedatives or tranquilizers
When Using This Product
- Drowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
- Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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.
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.
- Do not take more than directed (see
- Overdose warning)
- Adults and children 12 years and overtake 2 caplets at bedtimedo not take more than 2 caplets of this product in 24 hourschildren under 12 yearsdo not use
- Store between 20-25°C (68-77°F) in a dry placeretain carton for complete product information
Colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
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