PediaCare Infant Fever Pain Reliever

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Medtech Products Inc.
NDC Code: 63029-700

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.

PediaCare Infant Fever Pain Reliever_flavors

Drug Facts – Cherry Flavor

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Uses:

temporarily reduces fever; temporarily relieves minor aches and pains due to:

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

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

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

Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are unsure 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 dosage (see overdose warning)

Stop use and ask a doctor if:
  • pain gets worse or lasts for more than 5 days.
  • fever gets worse or lasts for 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 (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • This product does not contain directions or complete warnings for adult use.
  • Shake well before using.
  • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • Remove cap and insert syringe into hole at top of bottle and turn upside down.
  • Pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not use more than 5 times in 24 hours (see overdose warning).
  • Replace cap tightly to maintain child resistance.
  • mL = milliliter, tsp = teaspoon
Weight (lb)Age (yr)Dose (mL)
under 24under 2Ask a doctor
24-352-35 mL

Other information
  • store at room temperature
  • each teaspoon contains: sodium 2 mg
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 40, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

Call 1-888-474-3099 Mon. – Fri. 8:00 am to 8:00 pm EST or visit us at www.PediaCare.com.







Drug Facts – Bubble Gum Flavor

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Uses:

temporarily reduces fever; temporarily relieves minor aches and pains due to:

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

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

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

Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are unsure 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 dosage (see overdose warning)

Stop use and ask a doctor if:
  • pain gets worse or lasts for more than 5 days.
  • fever gets worse or lasts for 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 (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • This product does not contain directions or complete warnings for adult use.
  • Shake well before using.
  • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • Remove cap and insert syringe into hole at top of bottle and turn upside down.
  • Pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not use more than 5 times in 24 hours (see overdose warning).
  • Replace cap tightly to maintain child resistance.
  • mL = milliliter, tsp = teaspoon
Weight (lb)Age (yr)Dose (mL)
under 24under 2Ask a doctor
24-352-35 mL

Other information
  • store at room temperature
  • each teaspoon contains: sodium 2 mg
  • see bottom panel for lot number and expiration date

Inactive ingredients

butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 33, red 40, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-888-474-3099 Mon. – Fri. 8:00 am to 8:00 pm EST or visit us at www.PediaCare.com.







Drug Facts – Grape Flavor

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Uses:

temporarily reduces fever; temporarily relieves minor aches and pains due to:

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

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

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

Do not use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are unsure 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 dosage (see overdose warning)

Stop use and ask a doctor if:
  • pain gets worse or lasts for more than 5 days.
  • fever gets worse or lasts for 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 (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • This product does not contain directions or complete warnings for adult use.
  • Shake well before using.
  • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  • Remove cap and insert syringe into hole at top of bottle and turn upside down.
  • Pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not use more than 5 times in 24 hours (see overdose warning).
  • Replace cap tightly to maintain child resistance.
  • mL = milliliter, tsp = teaspoon
Weight (lb)Age (yr)Dose (mL)
under 24under 2Ask a doctor
24-352-35 mL

Other information
  • store at room temperature
  • each teaspoon contains: sodium 2 mg
  • see bottom panel for lot number and expiration date

Inactive ingredients

blue 1, butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 33, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-888-474-3099 Mon. – Fri. 8:00 am to 8:00 pm EST or visit us at www.PediaCare.com.







PRINCIPAL DISPLAY PANEL

NEW Accurate Dosing
INFANTS 0-36 months
PediaCare® we care for kidsTM
Fever Reducer Pain Reliever
ACETAMINOPHEN Oral Suspension
Cherry Flavor
2 FL OZ (59 mL)


PRINCIPAL DISPLAY PANEL

NEW Accurate Dosing
INFANTS 0-36 months
PediaCare® we care for kidsTM
Fever Reducer Pain Reliever
ACETAMINOPHEN Oral Suspension
Bubble Gum Flavor
2 FL OZ (59 mL)



PRINCIPAL DISPLAY PANEL

NEW Accurate Dosing
INFANTS 0-36 months
PediaCare® we care for kidsTM
Fever Reducer Pain Reliever
ACETAMINOPHEN Oral Suspension
Grape Flavor
2 FL OZ (59 mL)

PEDIACARE INFANT FEVER PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-700
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
POWDERED CELLULOSE 
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
FD&C RED NO. 40 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-700-011 BOTTLE, WITH APPLICATOR (1 BOTTLE) in 1 CARTON
159 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34310/15/2011
PEDIACARE INFANT FEVER PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-733
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
POWDERED CELLULOSE 
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
FD&C RED NO. 40 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
D&C RED NO. 33 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-733-011 BOTTLE, WITH APPLICATOR (1 BOTTLE) in 1 CARTON
159 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34310/15/2011
PEDIACARE INFANT FEVER PAIN RELIEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-722
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
POWDERED CELLULOSE 
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-722-011 BOTTLE, WITH APPLICATOR (1 BOTTLE) in 1 CARTON
159 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34310/15/2011
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIOperations
Aaron Industries Inc113044205MANUFACTURE

Revised: 11/2011
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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