Pediatric Acephentm,

Pediatric Acephentm,
SPL v1
SPL
SPL Set ID c383bf5b-7043-4f0c-bddb-590aea545859
Route
RECTAL
Published
Effective Date 2012-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (120 mg)
Inactive Ingredients
Butylated Hydroxyanisole Butylated Hydroxytoluene Glyceryl Monostearate Hydrogenated Coconut Oil Peg-100 Stearate Polysorbate 80

Identifiers & Packaging

Marketing Status
NDA Active Since 2006-06-29

Description

Acetaminophen 120 mg

Purpose

pain reliever/fever reducer


Medication Information

Purpose

pain reliever/fever reducer

Description

Acetaminophen 120 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 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.

Questions

call 1-800-922-1038

Monday-Friday 9am-4pm EST

Other Information

• 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)

Inactive Ingredient

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

Dosage & Administration

Directions

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

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.

Package Label.principal Display Panel

SEE NEW WARNINGS INFORMATION

READ AND KEEP CARTON FOR NEW LIVER WARNING

NDC 54868-5624-0

12 rectal suppositories

Acetaminophen Suppositories USP 120 mg

ASPIRIN FREE

Pain Reliever • Fever Reducer

50 Rectal Suppositories

Active Ingredient (in Each Rectal Suppository)

Acetaminophen 120 mg


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 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.

Questions (QUESTIONS)

call 1-800-922-1038

Monday-Friday 9am-4pm EST

Other Information

• 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)

Inactive Ingredient (INACTIVE INGREDIENT)

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

Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

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

Keep Out of Reach of Children (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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

SEE NEW WARNINGS INFORMATION

READ AND KEEP CARTON FOR NEW LIVER WARNING

NDC 54868-5624-0

12 rectal suppositories

Acetaminophen Suppositories USP 120 mg

ASPIRIN FREE

Pain Reliever • Fever Reducer

50 Rectal Suppositories

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

Acetaminophen 120 mg


Advanced Ingredient Data


Raw Label Data

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