PEDIACARE SINGLE DOSE FEVER REDUCER- acetaminophen liquid

PediaCare Single Dose Fever Reducer by

Drug Labeling and Warnings

PediaCare Single Dose Fever Reducer by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

INGREDIENTS AND APPEARANCE

PEDIACARE SINGLE DOSE FEVER REDUCER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-075
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-075-07	7 in 1 BOX, UNIT-DOSE
1		7.5 mL in 1 DOSE PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/15/2013

PEDIACARE SINGLE DOSE FEVER REDUCER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-010-10	6 in 1 BOX, UNIT-DOSE
1		10 mL in 1 DOSE PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/15/2013

Labeler - Medtech Products Inc. (122715688)