OTC Medication Information: ACEPHEN

ACEPHEN- acetaminophen suppository
Preferred Pharmaceuticals Inc.

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)
• do not use if imprinted suppository wrapper is opened or damaged

INACTIVE INGREDIENTS

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

QUESTIONS ?

call 1-800-922-1038

PRINCIPAL DISPLAY PANEL

NDC 68788-8934
ACEPHENTM ACETAMINOPHEN SUPPOSITORIES USP 325 mg
Pain Reliever • Fever Reducer
12 Rectal Suppositories

Acetaminophen Suppositories 325mg
(click image for full-size original)
ACEPHEN acetaminophen suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8934(NDC:0713-0164)
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Inactive Ingredients
Ingredient Name Strength
Glyceryl Monostearate
Hydrogenated Coconut Oil
Peg-100 Stearate
Sorbitan Monooleate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8934-1 12 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 1 SUPPOSITORY in 1 BLISTER PACK This package is contained within the BOX (68788-8934-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072344 02/12/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-8934)

Revised: 02/2018 Preferred Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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