ACETAMINOPHEN

Physicians Total Care, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each rectal suppository)
• Purpose
• ACETAMINOPHEN Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• ACETAMINOPHEN Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Active ingredient (in each rectal suppository)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

ACETAMINOPHEN 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

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

ACETAMINOPHEN Other information

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

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

PRINCIPAL DISPLAY PANEL

Acetaminophen Suppositories USP, 650 mg

NDC 54868-4991-0

Pain Reliever/Fever Reducer

See New Warnings Information

Read and Keep Carton for New Liver Warning

650 mg Each