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ACEPHEN

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

AcephenAcetaminophen Suppositories USP325 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT (in each rectal suppository)

Acetaminophen 325 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
 a child 6 to 12 years takes more than 5 doses in 24 hours
•  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 6 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
• new symptoms occur
• pain gets worse or lasts more than 10 days
• 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
• insert suppository well up into rectum

children under 6 years                       do not use
children 6-12 years

                      1 suppository every 4 to 6 hours

                       (maximum of 5 doses in 24 hours)

adults and children

12 years and older

                       2 suppositories every 4 to 6 hours

                       (maximum of 6 doses)

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 0713-0164-01
G&W®
ACEPHENTM ACETAMINOPHEN SUPPOSITORIES USP 325 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

ACEPHEN

Acetaminophen SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0713-0164
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 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:0713-0164-12 12 in 1 BOX
2 NDC:0713-0164-01 100 in 1 BOX
3 NDC:0713-0164-50 50 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072344 1992-03-27


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