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.
Active Ingredients (In Each Caplet)
Acetaminophen 500 mgDiphenhydramine HCl 25 mg
Pain relieverNighttime sleep-aid
- •temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 4,000 mg of acetaminophen in 24 hours •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this product
- Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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 skin •in children under 12 years of age •if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If You Have
- •liver disease •glaucoma •a breathing problem such as emphysema or chronic bronchitis •trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking
- •the blood thinning drug warfarin •sedatives or tranquilizers
When Using This Product
- •drowsiness will occur •avoid alcoholic drinks •be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- •sleeplessness 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 days •redness or swelling is present •any new symptoms appearThese could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 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 of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor •do not give to children under 12 years of age
Colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, stearic acid, talc, titanium dioxide
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