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Name:Acephen
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.

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Drug Facts

Active ingredient

Drug Facts

Active Ingredient (in each rectal suppository)

Acetaminophen 650 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

SEE NEW WARNINGS INFORMATION

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.

WARNINGS:

For rectal use only

Liver Warnings: This product contains acetaminophen. Severe liver damage may occur if you take

-an adult or child 12 years and older takes more than 6 suppositories in 24 hours, which is the maximum daily amount

-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 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

Ask a doctor before use if 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.

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 suppositories in any 24-hour period

children under 12 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.

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

Questions? call 1-800-922-1038

AcephenTM

Acetaminophen Suppositories USP 650 mg

10 Rectal Suppositories

Repackaged by Cardinal Health

Zanesville, OH 43701

L3299120-11110

L3299120-21110

Package/Label Principal Display Panel

AcephenTM

Acetaminophen Suppositories USP 650 mg

10 Rectal Suppositories

label

Package/Label Principal Display Panel

label 2

ACEPHEN 
acetaminophen suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-8850(NDC:0713-0165)
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 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:55154-8850-0 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 (55154-8850-0)

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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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