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ACEPHEN

G&W Laboratories, Inc.
G&W Laboratories, Inc.

Pediatric AcephenAcetaminophen Suppositories, 120 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 120 mg

pain reliever/fever reducer

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

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.

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
 

• 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)

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

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 Type Human otc drug label Item Code (Source) NDC:0713-0118
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Marketing Start Date Marketing End Date
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 1982-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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