PediaCare Infants Fever Reducer Grape description, usages, side effects, indications, overdosage, supplying and lots more!

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PediaCare Infants Fever Reducer Grape

Blacksmith Brands, Inc.

PediaCare Infants Fever Reducer Grape




FULL PRESCRIBING INFORMATION

Drug Facts

(in each 0.8 mL )

Acetaminophen 80mg

Pain reliever/fever reducer

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • sore throat
  • toothache
  • headache

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

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

your child has liver disease.

if your child is taking the blood thinning drug warfarin.

do not exceed recommended dose.

(see overdose warning)

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

  • do not give more than directed (see overdose warning)
  • shake well before use
  • this product does not contain directions or complete warnings for adult use
  • use only with enclosed dosing device
  • fill to dose level
  • dispense liquid slowly into child’s mouth towards inner cheek
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • use dropper to close bottle and maintain child resistance
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) Age (yr) Dose ( mL )
Under 24 Under 2 ask a doctor
24-35 2-3 1.6 mL (0.8 + 0.8 mL)

store between 20-25ºC (68-77ºF)

butyl paraben, citric acid, D&C Red #33, FD&C blue #1, flavor, glycerin, maltitol, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum.

call 1-888-474-3099

Distributed by:
Blacksmith Brands Inc.
200 White Plains Road
Tarrytown, NY 10591 USA
© 2010

NEW PediaCare® Infants
Fever Reducer Pain Reliever
Ludens® Grape Taste!
1 FL OZ (30 mL)

PediaCare Infants Fever Reducer Grape

PediaCare Infants Fever Reducer Grape

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52183-373
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
Citric acid
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
MALTITOL
propylene glycol
PROPYLPARABEN
water
Sucralose
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, DROPPER
2 NDC:52183-373-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-08-03


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