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Perrigo New York Inc

Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each rectal suppository)

Acetaminophen 120 mg

Purpose

Pain reliever/fever reducer

acetaminophen 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

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

acetaminophen Other information

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

Inactive ingredients

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

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Compare to FeverAll® active ingredient

For Children

Acetaminophen Suppositories USP, 120 mg

Pain Reliever/Fever Reducer

See New Warnings Information

Read and Keep Carton for New Liver Warning

120 mg Each

acetaminophen
Acetaminophen Suppositories USP, 120 mg Carton Image 1 Acetaminophen Suppositories USP, 120 mg Carton Image 2

acetaminophen

Acetaminophen SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45802-732
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 120 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 6 in 1 BLISTER PACK
3 NDC:45802-732-30 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070607 2010-12-14


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Be sure to consult your doctor before taking any medication!
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