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.
Acetaminophen 500 mgDiphenhydramine HCl 25 mg
- Fever Reducer/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• rash If 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 ingredientsAsk a doctor before use if you have• a sodium-restricted diet.• liver disease• a breathing problem such as emphysema or chronic bronchitis• trouble urinating due to an enlarged prostate gland• glaucomaAsk a doctor or pharmacist before use if you are• taking the blood thinning drug warfarin• taking sedatives or tranquilizersWhen using this product• drowsiness will occur• avoid alcoholic drinks• do not drive a motor vehicle or operate machineryStop 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 occur• These could be signs of a serious condition.If pregnant or breast-feeding,ask a health professional before use.Overdose warning: 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 and over:• take 2 tablets fully dissolved in 8oz of water at bedtime.• do not take more than 2 tablets of this product in 24 hoursChildren under 12 years: do not use
Each tablet contains:Sodium 192 mgStore at room temperature 68 F-77 F (20oC-25oC)
Anhydrous citric acid, dimethicone, flavors, mannitol, polyethylene glycol 6000, polysorbate 20, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium citrate, sucralose
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