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 productAllergy alert: 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
- •in children under 12 years of age •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 •if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- •liver disease •glaucoma •trouble urinating due to an enlarged prostate gland •a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
- •taking sedatives or tranquilizers •taking the blood thinning drug warfarin
When Using This Product
- •drowsiness will occur •avoid alcoholic drinks •do not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
- •new symptoms occur •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 days •fever gets worse or lasts more than 3 days •redness or swelling is presentThese could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
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.
- •do not take more than directed (see overdose warning)adults and children 12 years and over •take 2 caplets at bedtime •do not take more than 2 caplets of this product in 24 hourschildren under 12 yearsdo not use
Carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
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