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.
(in each gelcap)Acetaminophen, USP 500 mgDiphenhydramine HCl, USP 25 mg
Pain relieverNighttime sleep aid
Temporary relief of occasional headaches and minor aches and pains with accaompanying sleeplessness.
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 have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
■ liver disease■ a breathing problem such as emphysema or chronic bronchitis■ trouble urinating due to an enlarged prostate gland■ glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking the blood thinning drug warfarin■ taking sedatives or tranquilizers
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
■ 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 present■ new symptoms occurThese could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
Taking more than the recommended dose (overdose) may cause liver damage. 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 gelcaps at bedtime■ do not take more than 2 gelcaps of this product in 24 hourschildren under 12 years: do not use
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.■ see bottom of the panel for expiration date and lot number
Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C Yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.
* Please review the disclaimer below.