Perrigo Acetaminophen Suppositories Usp, 650 Mg Drug Facts

Perrigo Acetaminophen Suppositories Usp, 650 Mg Drug Facts
SPL v7
SPL
SPL Set ID b43974c3-4db9-4201-beee-b22596a2b241
Route
RECTAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Cottonseed Oil

Identifiers & Packaging

Marketing Status
ANDA Active Since 2010-10-28 Until 2026-11-30

Description

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 650 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

  • 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.

For rectal use only

Directions
  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum
  • adults and children 12 years and older:
  • 1 suppository every 4 to 6 hours while symptoms last
  • do not exceed 6 suppositories in any 24 hour period
  • children under 12 years: ask a doctor
Do Not Use
  • in children under 12 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.
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

Principal Display Panel

Compare to FeverAll® active ingredient

For Adults

Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

Ages 12 years and older

12 RECTAL SUPPOSITORIES, 650 mg EACH

Padagis®

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.
  • pain gets worse or lasts more than 10 days.
  • new symptoms occur.
  • 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. (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 650 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

  • 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.

For rectal use only

Directions
  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum
  • adults and children 12 years and older:
  • 1 suppository every 4 to 6 hours while symptoms last
  • do not exceed 6 suppositories in any 24 hour period
  • children under 12 years: ask a doctor
Do Not Use (Do not use)
  • in children under 12 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.
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

Principal Display Panel

Compare to FeverAll® active ingredient

For Adults

Acetaminophen Suppositories USP, 650 mg

Pain Reliever/Fever Reducer

Ages 12 years and older

12 RECTAL SUPPOSITORIES, 650 mg EACH

Padagis®

Ask A Doctor Before Use If (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 (Stop use and ask a doctor if)
  • fever lasts more than 3 days (72 hours), or recurs.
  • pain gets worse or lasts more than 10 days.
  • new symptoms occur.
  • redness or swelling is present in the painful area. These may be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 650 mg


Advanced Ingredient Data


Raw Label Data

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