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.

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Active ingredient

Drug Facts

Active Ingredient (in each rectal suppository)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of reach of children.

Uses

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

Warnings

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.

Directions

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

Storage

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 @ www.gwlabs.com

ACEPHENTM

Acetaminophen Suppositories USP 325 mg

10 rectal suppositories

Repackaged by Cardinal Health

Zanesville, OH 43701

L35752710309

Package/Label Principal Display Panel

AcephenTM

Acetaminophen Suppositories USP 325 mg

10 Rectal Suppositories

ACEPHEN
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
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE
HYDROGENATED CASTOR OIL
PEG-100 STEARATE
SORBITAN MONOOLEATE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	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)

Establishment
Name	Address	ID/FEI	Operations
Cardinal Health		188557102	REPACK

Revised: 06/2011 Cardinal Health