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ACEPHEN

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

AcephenAcetaminophen Suppositories USP650 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (in each rectal suppository)

Acetaminophen 650 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
an adult or child 12 years and 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                               
• 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.

If pregnant or breast-feeding, ask a health professional before use.

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

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
  

OTHER INFORMATION

• store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENTS

glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate

QUESTIONS?

call 1-800-922-1038

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0165-01
G&W ACEPHENTM Acetaminophen Suppositories USP 650 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

ACEPHEN

Acetaminophen SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0713-0165
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERYL MONOSTEARATE
HYDROGENATED COCONUT OIL
PEG-100 STEARATE
SORBITAN MONOOLEATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0713-0165-12 12 in 1 BOX
2 NDC:0713-0165-01 100 in 1 BOX
3 NDC:0713-0165-50 50 in 1 BOX
4 NDC:0713-0165-10 1000 in 1 BOX
5 NDC:0713-0165-05 500 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072237 1992-03-27


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