Acetaminophen Diphenhydramine HCl
Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Pharmacy Value Alliance, LLC
NDC Code: 68016-659
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
(in each gelcap)
Acetaminophen, USP 500 mg
Diphenhydramine HCl 25 mg
Nighttime sleep aid
temporary relief of occasional headaches and minor aches and pains with accompanying 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 reaction. Symptoms may include:
■ skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
■ 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
■ liver disease
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery
■ 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.
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 hours
children under 12 years
- do not use
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for lot number and expiration date
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.
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
|ACETAMINOPHEN DIPHENHYDRAMINE HCL
acetaminophen diphenhydramine hcl tablet
|Labeler - Pharmacy Value Alliance, LLC (101668460)|
Medically reviewed on Nov 30, 2017
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.