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Manufacturer:Cardinal Health
Category:Over-the-counter (OTC) Marketed Drugs

Drug Facts

ACEPHEN - acetaminophen suppository 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


Drug Facts

Active ingredient

Drug Facts

Active Ingredient (in each rectal suppository)

Acetaminophen 325 mg


Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of reach of children.


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


For rectal use only. This package is intended for in-institution use only.

Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use in children under 6 years.

Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs or if you need to use this product for pain for more than 10 days continuously (adults) or 5 days (children).

Severe or recurrent pain, or high or continued fever may indicate a serious illness. If pregnant or breast-feeding, 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 for children even if you do not notice any signs or symptoms.


Do not use more than directed

remove foil wrapper

insert suppository well up into rectum

adults and children

12 years and over

2 suppositories every 4 to 6 hours while symptoms persist; do not exceed 12 suppositories in any 24 hour period
children 6-12 years 1 suppository every 4 to 6 hours while symptoms persist; do not exceed 6 suppositories in any 24 hour period
children under 6 years do not use

Inactive ingredients

glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate


Store at Room Temperature 15-30- C (59-86 F)

TAMPER-EVIDENT: Individually sealed in foil for your protection. For your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.

Other Information

Established since 1919, G&W Laboratories, Inc. is one of the largest manufacturers of quality suppositories in the United States. We take special care to ensure that all products are of the finest quality you can buy. SATISFACTION GUARANTEED OR YOUR MONEY BACK FROM G&W

G&W Laboratories, Inc.

111 Coolidge Street

South Plainfield, NJ 07080

Visit our website @


Acetaminophen Suppositories USP 325 mg

10 rectal suppositories

Repackaged by Cardinal Health

Zanesville, OH 43701


Package/Label Principal Display Panel


Acetaminophen Suppositories USP 325 mg

10 Rectal Suppositories


acetaminophen suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1124(NDC:0713-0164)
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:55154-1124-0 10 BLISTER PACK ( BLISTER PACK) in 1 BAG contains a BLISTER PACK
1 1 SUPPOSITORY ( SUPPOSITORY) in 1 BLISTER PACK This package is contained within the BAG (55154-1124-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/06/2011

Labeler - Cardinal Health (188557102)
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK

Revised: 06/2011 Cardinal Health

Reproduced with permission of U.S. National Library of Medicine

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