Perrigo Acetaminophen Suppositories Usp, 120 Mg Drug Facts

Perrigo Acetaminophen Suppositories Usp, 120 Mg Drug Facts
SPL v22
SPL
SPL Set ID a9864f73-abb2-4cb1-a692-a48efdeeedf8
Route
RECTAL
Published
Effective Date 2025-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (120 mg)
Inactive Ingredients
Cottonseed Acid

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2010-12-14 Until 2026-09-30

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
Purposes

Pain reliever/fever reducer

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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.

For rectal use only

Directions
  • this product does not contain directions or warnings for adult use
  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum

Dosing Chart

Age

Dose

under 3 years

Do not use unless directed by a doctor

3 to 6 years

Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Do Not Use
  • 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.
Other Information
  • store at 20-25°C (68-77°F) or in a cool place
  • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
Inactive Ingredient

hydrogenated vegetable oil

Questions Or Comments?

1-800-719-9260

Acetaminophen for Children
Ask A Doctor Before Use If
  • your child has liver disease
  • 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.
  • pain lasts more than 5 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area. These may be signs of a serious condition.
Keep Out of Reach of Children.

If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Rectal Suppository)

Acetaminophen 120 mg


Structured Label Content

Uses

temporarily

  • reduces fever
  • relieves minor aches, pains, and headache
Purposes

Pain reliever/fever reducer

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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.

For rectal use only

Directions
  • this product does not contain directions or warnings for adult use
  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum

Dosing Chart

Age

Dose

under 3 years

Do not use unless directed by a doctor

3 to 6 years

Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Do Not Use (Do not use)
  • 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.
Other Information (Other information)
  • store at 20-25°C (68-77°F) or in a cool place
  • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
Inactive Ingredient (Inactive ingredient)

hydrogenated vegetable oil

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Acetaminophen for Children (Acetaminophen For Children)
Ask A Doctor Before Use If (Ask a doctor before use if)
  • your child has liver disease
  • your child is taking the blood thinning drug warfarin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • fever lasts more than 3 days (72 hours), or recurs.
  • pain lasts more than 5 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area. These may be signs of a serious condition.
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. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

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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