DESCRIPTION
Active Ingredient (in each rectal suppository)
Acetaminophen 650 mg
Inactive Ingredients
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
INDICATIONS
Purpose
Pain reliever/fever reducer
Uses
temporarily
- reduces fever
- relieves minor aches, pains, and headache
DOSAGE AND ADMINISTRATION
Directions
- do not use more than directed
- remove foil wrapper
- carefully insert suppository well up into rectum
- adults and children 12 years and older
- 1 suppository every 4 to 6 hours while symptoms persist
- do not exceed 6 doses in any 24-hour period
- children under 12 years : do not use
HOW SUPPLIED
Dosage Forms And Strengths
NDC 0713-0165-01
Storage
- store at 15°-30°C (59°-86°F)
G&W Laboratories, Inc. Revised: Jan 2012
WARNINGS
For rectal use only
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.
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. Quick medical attention is critical in case of overdose for adults and
for children even if you do not notice any signs or symptoms If swallowed, get medical help or contact a poison control center right away.
PRECAUTIONS
See WARNINGS above.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.