FeverALL Infants description, usages, side effects, indications, overdosage, supplying and lots more!

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FeverALL Infants

Actavis Mid Atlantic LLC

FeverAll ® (Acetaminophen Suppositories) INFANTS




FULL PRESCRIBING INFORMATION

Acetaminophen, USP 80 mg

Pain reliever/fever reducer

Temporarily

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

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

  • more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
  • more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
  • 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

  • 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
  • the child has liver disease.
  • the child is taking the blood thinning drug warfarin.
  • fever lasts more than 3 days (72 hours), or recurs.
  • pain lasts more than 3 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

These may be signs of a serious condition.

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 adults and for children even if you do not notice any signs or symptoms.

  • 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 6 months  Do not use unless directed by a doctor
 6 to 11 months  Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours)
 12 to 36 months  Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other information

  • store at 2º-27ºC (35º-80ºF)
  • do not use if imprinted suppository wrapper is opened or damaged

Glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Infants’

Ages 6-36 months

80 mg

NDC 0472-1200-06

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

6 Rectal Suppositories

80 mg each

FeverALL Infants

FeverALL Infants

acetaminophen SUPPOSITORY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0472-1200
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERYL MONOSTEARATE
polysorbate 80
Hydrogenated Palm Kernel Oil
PEG-100 STEARATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0472-1200-06 6 in 1 BOX
2 NDC:0472-1200-50 50 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018337 1980-04-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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