![ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [G&W LABORATORIES, INC.]](https://medic.hrt.org//dailymed/images/20fae2ab-fcce-b026-be00-d9aa2f396f7d/Acephen.jpg)
- Active Ingredient (in each rectal suppository)
- PURPOSE
- USES
- WARNINGS
For rectal use only
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Liver Warning: This product contains acetaminophen. Severe liver damage may occur if
• a child 6 to 12 years takes more than 5 doses in 24 hours
• 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 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.
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. - DIRECTIONS
• do not use more than directed
• remove foil wrapper
• insert suppository well up into rectumClosechildren under 6 years do not use children 6-12 years 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) adults and children 12 years and older 2 suppositories every 4 to 6 hours (maximum of 6 doses) - Other Information
• store at room temperature 15˚-30˚C (59˚-86˚F)
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• do not use if imprinted suppository wrapper is opened or damaged - INACTIVE INGREDIENTS
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
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- PRINCIPAL DISPLAY PANEL
NDC 0713-0164-01
ACEPHENTM ACETAMINOPHEN SUPPOSITORIES USP 325 mg
Pain Reliever • Fever Reducer
100 Rectal SuppositoriesClose
- INGREDIENTS AND APPEARANCE
ACEPHEN
acetaminophen suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0713-0164 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Inactive Ingredients Ingredient Name Strength Glyceryl Monostearate (UNII: 230OU9XXE4) Hydrogenated Coconut Oil (UNII: JY81OXM1OM) Peg-100 Stearate (UNII: YD01N1999R) Sorbitan Monooleate (UNII: 06XEA2VD56) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0713-0164-01 100 in 1 BOX 03/27/1992 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0713-0164-50 50 in 1 BOX 03/27/1992 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0713-0164-12 12 in 1 BOX 03/27/1992 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 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) CloseEstablishment Name Address ID/FEI Business Operations G&W Laboratories, Inc. 001271188 MANUFACTURE(0713-0164)