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Acephen by Cardinal Health

Dosage form: suppository
Ingredients: ACETAMINOPHEN 325mg
Labeler: Cardinal Health
NDC Code: 55154-1124

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

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 years1 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1124(NDC:0713-0164)
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
HYDROGENATED CASTOR OIL 
PEG-100 STEARATE 
SORBITAN MONOOLEATE 
Packaging
#Item CodePackage Description
1NDC:55154-1124-010 BLISTER PACK in 1 BAG
11 SUPPOSITORY in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/06/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-1124)

Revised: 01/2012
 
Cardinal Health

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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