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ACEPHEN by G&W Laboratories, Inc.

Dosage form: suppository
Ingredients: Acetaminophen 120mg
Labeler: G&W Laboratories, Inc.
NDC Code: 0713-0118

Pediatric AcephenTM Acetaminophen Suppositories, 120 mg

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
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.
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.

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 ingredients

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0118
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen120 mg
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxyanisole 
Butylated Hydroxytoluene 
Glyceryl Monostearate 
Hydrogenated Coconut Oil 
Peg-100 Stearate 
Polysorbate 80 
Packaging
#Item CodePackage Description
1NDC:0713-0118-1212 SUPPOSITORY (SUPPOSITORY) in 1 BOX
2NDC:0713-0118-01100 SUPPOSITORY (SUPPOSITORY) in 1 BOX
3NDC:0713-0118-5050 SUPPOSITORY (SUPPOSITORY) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01806001/01/1982
Labeler - G&W Laboratories, Inc. (001271188)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIOperations
G&W Laboratories, Inc.001271188MANUFACTURE(0713-0118)

Revised: 01/2012
 
G&W Laboratories, Inc.

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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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