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 mg and Diphenhydramine HCl 25 mg
Pain Reliever/Nightime 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 2 caplets in 24 hours, which is the maximum daily amount for this product
- With other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- In children under 12 years of age
- With any other product containing diphenhydramine, even one used on skin
- 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
- A breathing problem such as emphysema or chronic bronchitis
- Difficulty in urination due to enlargement of the prostate gland
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 a serious underlying medical illness.
- Pain gets worse or lasts more than 10 days
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is presentThese 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 of age or over:Take 2 caplets at bedtime if needed, or as directed by a doctorChildren under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- Store at room temperature
Croscarmellose Sodium, Crospovidone, FD&C Blue #1, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Propylene Glycol, Silica, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.
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