FDA Label for Only For Body Pain

Drug Facts

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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 1,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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 any allergic reaction to this product or any of its ingredients
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

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 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 continously 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.

Keep Out Of Reach Of Children

Overdose Warning: 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	2 caplets at bedtime do not take more than 2 caplets 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).

Inactive Ingredients:

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

Packaging

image description - label