ACTIVE INGREDIENT (in each rectal suppository)

Acetaminophen 120 mg

PURPOSE

pain reliever/fever reducer

USES

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

WARNINGS

For rectal use only
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child inserts:
• more than 5 suppositories in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Do not use
• if your child is 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 your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if
• fever lasts more than 3 days (72 hours), or recurs
• you need to use this product for pain for more than 5 days continuously
Severe or recurrent pain, or high or continued fever may indicate a serious illness.

KEEP OUT OF REACH OF CHILDREN

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 children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
This product does not contain directions or complete warnings for adult use.
• do not use more than directed
• remove foil wrapper
• insert suppository well up into rectum
• children 3-6 years:
• 1 suppository every 4 to 6 hours while symptoms persist
• do not exceed 5 suppositories in any 24-hour period
• children under 3 years: ask a doctor

Other Information

• for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
• store at 8˚-25˚C (46˚-77˚F)

INACTIVE INGREDIENT

butylated hydroxyanisole, butylated hydroxytoluene, glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, polysorbate 80

QUESTIONS

call 1-800-922-1038
Monday-Friday 9am-4pm EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS INFORMATION
READ AND KEEP CARTON FOR NEW LIVER WARNING
NDC 0713-0118-50
G&W Pediatric ACEPHENTM Acetaminophen Suppositories USP 120 mg
ASPIRIN FREE
Pain Reliever • Fever Reducer
50 Rectal Suppositories

ACEPHEN
acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0713-0118
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (Acetaminophen)	Acetaminophen	120 mg

Inactive Ingredients
Ingredient Name	Strength
Butylated Hydroxyanisole
Butylated Hydroxytoluene
Glyceryl Monostearate
Hydrogenated Coconut Oil
Peg-100 Stearate
Polysorbate 80

Packaging
#	Item Code	Package Description
1	NDC:0713-0118-12	12 in 1 BOX
2	NDC:0713-0118-01	100 in 1 BOX
3	NDC:0713-0118-50	50 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018060	01/01/1982

Labeler - G&W Laboratories, Inc. (001271188)

Registrant - G&W Laboratories, Inc. (001271188)

Establishment
Name	Address	ID/FEI	Business Operations
G&W Laboratories, Inc.		001271188	MANUFACTURE

Revised: 01/2012

Document Id: 3caa1dd1-95f6-ad73-3875-bf1cbe2e761f

Set id: 32bbe845-7f0e-c33d-adb2-659f18fedfa9

Version: 1

Effective Time: 20120112

G&W Laboratories, Inc.