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US · Over-the-counter medicine

Only For BODY PAIN

Dosage form
TABLET
Labeler
O4 Global Trading Usa, Llc
Label updated
2020-11-19
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Nighttime sleep aid

Uses:

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings:

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 reactions.

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

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

glaucoma.

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 last 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.

Label information

Keep out of reach of children.

OVERDOSE WARNINGS:  In case of accidental overdose, get medical help or contact a Poison Control Center 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:

take with a full glass of water

Do not take more than directed. SEE OVERDOSE WARNING.

do not take more than 2 caplets in 24 hours

adults and children 12 years of age and over

 • take 2 caplets at bedtime

 • do not take more than 2 caplets of this product in 24 hours

 children under 12 years of age  • do not use

Other Information:

Store at room temperature between 20-25°C (68-77°F).

avoid excessive heat, cold and humidity.

close cap tightly after use.

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, FD&C blue No.1, hydroxy propyl methyl cellulose, magnesium stearate, starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions or comments?

1-833-665-9444. (Mon-Fri 9am-5pm)

Label information

ADULT

PAIN RELIEVER NIGHTTIME SLEEP AID

TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing

Distributed By: O4 GLOBAL TRADING USA, LLC.

12222 Merit Drive, Suite 1900

Dallas, TX 75251-3209

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc.

East Brunswick, NJ 08816.

Packaging

[Image in the official label — see DailyMed source]

DailyMed Set ID: ff61406a-ca7c-4b8d-a730-8bdbceab0389 · Version 1
NDC: 73006-120