ACEPHEN- acetaminophen suppository 
Cardinal Health

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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

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 warning: This product contains acetaminophen. Severe liver damage may occur if

-an adult or child 12 years or 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 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

-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 doses 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

G&W and ACEPHEN are trademarks owned by their respective owners.

Distributed by:

Cardinal Health

Dublin, OH 43017

L3299120-10218

L3299120-20218

Package/Label Principal Display Panel

Acephen

Acetaminophen Suppositories USP 650 mg

10 Rectal Suppositories

bag label
ACEPHEN 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8850(NDC:0713-0165)
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-8850-010 in 1 BAG06/06/201108/31/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07223706/06/201108/31/2018
Labeler - Cardinal Health (603638201)

Revised: 5/2020
 
Cardinal Health