PEDIACARE INFANTS FEVER REDUCER DYE FREE- acetaminophen liquid

PediaCare Infants Fever Reducer Dye Free by

Drug Labeling and Warnings

PediaCare Infants Fever Reducer Dye Free by is a Otc medication manufactured, distributed, or labeled by Blacksmith Brands, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, 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
Dye Free Ludens® Cherry Taste!
1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

PEDIACARE INFANTS FEVER REDUCER DYE FREE 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-383
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg  in 0.8 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CITRIC ACID (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-383-01	1 in 1 BOX
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/28/2010

Labeler - Blacksmith Brands, Inc. (021411299)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE