Acephentm 

Acephentm 
SPL v1
SPL
SPL Set ID aa6314c7-e816-4bb5-811c-5975fce1f743
Route
RECTAL
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Glyceryl Monostearate Hydrogenated Coconut Oil Peg-100 Stearate Sorbitan Monooleate

Identifiers & Packaging

Marketing Status
ANDA Active Since 1992-03-27

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

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)

Questions?

call 1-800-922-1038

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

Active Ingredient (in Each Rectal Suppository)

Acetaminophen 325 mg

Principal Display Panel 325 Mg Suppository Box Label

CommUnityCare Federally Qualified Health Centers

Acetaminophen

325mg Supp.

Date:

Name:

Dr.

Hancock item only

123456

1/1/01

Acetaminophen 325mg Suppositories NDC 76413-302-12

Batch: 123456

Lot: 123456

Exp: 1/1/01

G&W LABS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


Structured Label Content

Uses (USES)

temporarily

• reduces fever

• relieves minor aches, pains, and headache

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (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 (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)

Questions? (QUESTIONS?)

call 1-800-922-1038

Other Information

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

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Active Ingredient (in Each Rectal Suppository) (ACTIVE INGREDIENT (in each rectal suppository))

Acetaminophen 325 mg

Principal Display Panel 325 Mg Suppository Box Label (PRINCIPAL DISPLAY PANEL - 325 mg Suppository Box Label)

CommUnityCare Federally Qualified Health Centers

Acetaminophen

325mg Supp.

Date:

Name:

Dr.

Hancock item only

123456

1/1/01

Acetaminophen 325mg Suppositories NDC 76413-302-12

Batch: 123456

Lot: 123456

Exp: 1/1/01

G&W LABS

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)