OTC Medication Information: PediaCare Infants Fever Reducer Cherry

PEDIACARE INFANTS FEVER REDUCER CHERRY- acetaminophen liquid
Blacksmith Brands, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients

(in each 0.8 mL )

Acetaminophen 80mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:

    • the common cold
    • flu
    • sore throat
    • toothache
    • headache

Warnings

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.

Do not use

  • 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.

Ask a doctor before use

if your child has liver disease.

Ask a doctor or pharmacist before use

if your child is taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dose.

(see overdose warning)

Stop use and ask a doctor if

  • 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.

Keep out of reach of children.

Overdose warning:

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.

Directions

  • 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)

Other information

store between 20-25ºC (68-77ºF)

Inactive ingredients:

butyl paraben, citric acid, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum.

Questions or comments?

call 1-888-474-3099

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL
PediaCare Infants Fever Reducer 
Cherry Flavor
(click image for full-size original)
PEDIACARE INFANTS FEVER REDUCER CHERRY acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-393
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
CITRIC ACID
FD&C RED NO. 40
GLYCERIN
MALTITOL
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52183-393-01 1 BOTTLE, DROPPER (1 BOTTLE) in 1 BOX contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (52183-393-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 08/27/2010
Labeler — Blacksmith Brands, Inc. (021411299)
Establishment
Name Address ID/FEI Operations
Guardian Drug Company 119210276 MANUFACTURE

Revised: 10/2010 Blacksmith Brands, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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