Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository 
Preferred Pharmaceuticals, Inc.

----------

Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen 120 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

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

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

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.

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.

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)

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 Children

Acetaminophen Suppositories USP, 120 mg

Pain Reliever/Fever Reducer

Ages 3-6 years

See New Warning

12 RECTAL SUPPOSITORIES, 120 mg EACH

Acetaminophen Suppositories for Children, USP 120mg
ACETAMINOPHEN  FOR CHILDREN
acetaminophen suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-0426(NDC: 45802-732)
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN120 mg
Inactive Ingredients
Ingredient NameStrength
COTTONSEED OIL (UNII: H3E878020N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-0426-112 in 1 CARTON12/14/2010
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07060712/14/201005/02/2019
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-0426)

Revised: 5/2019
Document Id: 16294994-8f07-4874-8852-6cec5417473b
Set id: 6444d200-e32c-4848-80c3-6a23a213fbad
Version: 10
Effective Time: 20190502