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 gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 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 takewith other drugs containing acetaminophenmore than 4,000 mg of acetaminophen in 24 hours3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf 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 skinif you are allergic to acetaminophen or any of the inactive ingredients in this productin children under 12 years of age
Ask A Doctor Before Use If You Have
- Liver diseasea breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandglaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking the blood thinning drug warfarintaking sedatives or tranquilizers
When Using This Product
- Drowsiness will occuravoid alcoholic beveragesdo not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
- Pain gets worse or lasts more than 10 dayssleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.new symptoms occurredness or swelling is presentfever gets worse or lasts more than 3 daysThese could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
Ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 directedadults and children 12 years and overtake 2 gelcaps at bedtimedo not take more than 2 gelcaps of this product in 24 hours.children under 12 years: do not use
- Avoid high humiditystore at 20º to 25°C (68º to 77°F)use by expiration date on package
Ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.
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