acetaminophen

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Full prescribing information#

Active ingredient (in each rectal suppository)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily

• reduces fever
• relieves minor aches, pains, and headache

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to FeverAll^® active ingredient

For Adults

Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

Ages 12 years and older

12 RECTAL SUPPOSITORIES, 650 mg EACH

Padagis_®

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• acetaminophen pain reliever fever reducer
• Acetaminophen
• COTTONSEED OIL

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Product history page 1 of 2 · 44 observed states.

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