Acetaminophen Diphenhydramine HCl
- Dosage form
- TABLET
- Labeler
- Granules USA, Inc.
- Label updated
- 2025-12-22
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
Active ingridients
(in each caplet)
Acetaminophen, USP 500mg
Diphenhydramine HCl. 25mg
Purposes
Pain reliever
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Liver warning
This product containsacetaminophen. 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 severs skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away
DSo 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
■ a breathing problem such as emphysema or chronic brochitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
Ask a doctor or pharmacist before use if you have
■ 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 morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
■ pain gets worse or lasts more t han 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 (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.
Directions
■ do not take more than directed (see overdose warning)
adults andchildren 12 years and over
■ take 2 caplets at bedtime do not use
■ do not take more than 2 caplets 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 ingridients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide
Principal Display Panel
[Image in the official label — see DailyMed source]
Principal Display Panel
[Image in the official label — see DailyMed source]
Principal Display Panel
[Image in the official label — see DailyMed source]
DailyMed Set ID: 8c9f68e3-fedc-6457-e053-2995a90a045a · Version 7
NDC: 69848-014