ACEPHEN
-
acetaminophen suppository
G&W Laboratories, Inc.
Acetaminophen 325 mg
Pain reliever/fever reducer
temporarily
• reduces fever
• relieves minor aches, pains, and headache
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 12 suppositories in 24 hours, which is the maximum daily amount
• a child 6 to 12 years takes more than 6 suppositories 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
Do not use
• in children under 6 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
• new symptoms occur
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
These may be signs of a serious condition.
ask a health professional before use.
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 children even if you do not notice any signs or symptoms.
Directions
• do not use more than directed
• remove foil wrapper
• insert suppository well up into rectum
children under 6 years | do not use |
children 6-12 years | 1 suppository every 4 to 6 hours |
adults and children 12 years and older | 2 suppositories every 4 to 6 hours |
• store at room temperature 15˚-30˚C (59˚-86˚F)
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
call 1-800-922-1038
SEE NEW WARNINGS INFORMATION
READ AND KEEP CARTON FOR NEW LIVER WARNING
NDC 0713-0164-50
G&W ACEPHENTM Acetaminophen Suppositories USP 325 mg
Pain Reliever • Fever Reducer
50 Rectal Suppositories
ACEPHEN
acetaminophen suppository | ||||||||||||||||||||||||
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA072344 | 03/27/1992 |
Labeler - G&W Laboratories, Inc. (001271188) |
Registrant - G&W Laboratories, Inc. (001271188) |
Establishment | |||
Name | Address | ID/FEI | Operations |
G&W Laboratories, Inc. | 001271188 | MANUFACTURE |