Active Ingredients
(in each gelcap)
Acetaminophen, USP 500 mg
Diphenhydramine HCl 25 mg
Acetaminophen Diphenhydramine Hcl
FDA Label NDC 68016-651
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Acetaminophen Diphenhydramine Hcl (NDC 68016-651). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever
Nighttime sleep aid
Uses
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 product
Allergy Alert
acetaminophen may cause severe skin reaction. 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 ingredients
Ask A Doctor Before Use If You Have
■ liver disease
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged 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 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 present
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
■ 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 hours
children under 12 years
- do not use
Other Information
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for expiration date and lot number.
Inactive Ingredients
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.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
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