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PEDIACARE SINGLE DOSE FEVER REDUCER (acetaminophen) liquid
[Medtech Products Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

CHILDREN
Ages 6-8 NEW!
or 48-59 lbs

Drug Facts

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Uses:

temporarily

  • reduces fever
  • 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 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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.

•       Each packet provides 1 dose for a child who is 48 to 59 pounds or 6 to 8 years of age. If possible, use weight to determine dose; otherwise use age.

To use:

•       Fold back at the dotted line to reveal the tear strip.

•       Tear across (not up & down) at the exposed tear slit

•       Remove and discard strip

•       Squeeze medicine into child’s mouth.

•       If needed, repeat dose every 4 hours while symptoms last.

•       Do not give more than 5 times in 24 hours (see overdose warning).

•       Do not give more than 5 days unless directed by a doctor.

Other information

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

Inactive ingredients

citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum

Questions or comments?

1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com

PRINCIPAL DISPLAY PANEL

Children Ages 6-8
or 48-59 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen
160mg/5mL
Oral Suspension
6 Single Dose Packets
0.34 FL OZ (10 mL) EACH

Children Ages 6-8
or 48-59 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen 
160mg/5mL
Oral Suspension
6 Single Dose Packets
0.34 FL OZ (10 mL) EACH

CHILDREN
Ages 4-5 NEW!
or 36-47 lbs

Drug Facts

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Fever reducer/pain reliever

Uses:

temporarily

  • reduces fever
  • 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 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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.

•       Each packet provides 1 dose for a child who is 36 to 47 pounds or 4 to 5 years of age. If possible, use weight to determine dose; otherwise use age.

To use:

•       Fold back at the dotted line to reveal the tear strip.

•       Tear across (not up & down) at the exposed tear slit

•       Remove and discard strip

•       Squeeze medicine into child’s mouth.

•       If needed, repeat dose every 4 hours while symptoms last.

•       Do not give more than 5 times in 24 hours (see overdose warning).

•       Do not give more than 5 days unless directed by a doctor.

Other information

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

Inactive ingredients

citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum

Questions or comments?

1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com

PRINCIPAL DISPLAY PANEL

Children Ages 4-5
or 36-47 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen
160mg/5mL
Oral Suspension
7 Single Dose Packets
0.25 FL OZ (7.5 mL) EACH

Children Ages 4-5
or 36-47 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen 
160mg/5mL
Oral Suspension
7 Single Dose Packets
0.25 FL OZ (7.5 mL) EACH

INGREDIENTS & APPEARANCE

PEDIACARE SINGLE DOSE FEVER REDUCER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63029-075
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
POTASSIUM SORBATE 
WATER 
SORBITOL 
XANTHAN GUM 
SUCRALOSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-075-077 in 1 BOX, UNIT-DOSE
17.5 mL in 1 DOSE PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/15/2013
PEDIACARE SINGLE DOSE FEVER REDUCER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63029-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
POTASSIUM SORBATE 
WATER 
SORBITOL 
XANTHAN GUM 
SUCRALOSE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-010-106 in 1 BOX, UNIT-DOSE
110 mL in 1 DOSE PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/15/2013
Labeler - Medtech Products Inc. (122715688)

Revised: 7/2013
 
Medtech Products Inc.