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Acetaminophen by Physicians Total Care, Inc.

Medically reviewed on June 6, 2018

Dosage form: suppository
Ingredients: Acetaminophen 120mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5624

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
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 54868-5624-0
12 rectal suppositories
Acetaminophen Suppositories USP 120 mg
ASPIRIN FREE
Pain Reliever • Fever Reducer
50 Rectal Suppositories

ACETAMINOPHEN 
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5624(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:54868-5624-012 SUPPOSITORY (SUPPOSITORY) in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01806006/29/2006
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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