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Acetaminophen Diphenhydramine HCl

Dosage form
TABLET
Labeler
Granules USA, Inc.
Label updated
2025-12-22
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
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