ACEPHEN- acetaminophen suppository

Acephen by

Drug Labeling and Warnings

Acephen by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACEPHEN 
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-8850(NDC:0713-0165)
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PEG-100 STEARATE (UNII: YD01N1999R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-8850-0	10 in 1 BAG	06/06/2011
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072237	06/06/2011

Labeler - Cardinal Health (603638201)