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FDA LABEL GENERIC: Acetaminophen MFR: Strategic Sourcing Services LLC

Apap 650 Mg Rectal Suppository

Active ingredient (in each rectal suppository)

Acetaminophen 650 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

reduces fever relieves minor aches, pains, and headache

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if

an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen an adult takes 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.

For rectal use only

Do not use

in children under 12 years if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

you have liver disease you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

fever lasts more than 3 days (72 hours), or recurs pain gets worse or lasts more than 10 days new symptoms occur redness or swelling is present in the painful area.

These may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed remove wrapper carefully insert suppository well up into the rectum adults and children 12 years and older: 1 suppository every 4 to 6 hours while symptoms last do not exceed 6 suppositories in any 24 hour period children under 12 years: ask a doctor

Other information

store at 20-25°C (68-77°F) or in a cool place tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.

Inactive ingredient

hydrogenated vegetable oil

Questions or comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

Foster & ThriveTM

FOR ADULTS

Pain Reliever

Acetaminophen Suppositories 650 mg

ACTUAL SIZE

PAIN RELIEVER/FEVER REDUCER

12 RECTAL SUPPOSITORIES, 650 mg EACH

Ages 12 years and older

SEE NEW WARNING