Pediacare Single Dose Fever Reducer

Pediacare Single Dose Fever Reducer
SPL v5
SPL
SPL Set ID 6032dc92-44e5-4f32-b1a6-bba6695d2dcc
Route
ORAL
Published
Effective Date 2013-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Cellulose, Microcrystalline Potassium Sorbate Water Sorbitol Xanthan Gum Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-15

Description

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

Purpose

Fever reducer/pain reliever


Medication Information

Purpose

Fever reducer/pain reliever

Description

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

Uses:

temporarily

  • reduces fever

  • relieves minor aches and pains due to:

          ○ the common cold

          ○ flu

          ○ headache

          ○ sore throat

          ○ toothache
Section 42229-5

CHILDREN

Ages 6-8 NEW!

or 48-59 lbs

Drug Facts

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.

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.

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.
Active Ingredient

(in each 5 mL )

Acetaminophen 160 mg

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

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.

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.


Structured Label Content

Uses:

temporarily

  • reduces fever

  • relieves minor aches and pains due to:

          ○ the common cold

          ○ flu

          ○ headache

          ○ sore throat

          ○ toothache
Section 42229-5 (42229-5)

CHILDREN

Ages 6-8 NEW!

or 48-59 lbs

Drug Facts

Purpose

Fever reducer/pain reliever

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.

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.

Do Not Use (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.
Active Ingredient (Active ingredient)

(in each 5 mL )

Acetaminophen 160 mg

Other Information (Other information)

•       Store at room temperature

•       See bottom panel for lot number and expiration date

•       Keep this box for future reference

Inactive Ingredients (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? (Questions or comments?)

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

Principal Display Panel (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

When Using This Product (When using this product)

do not exceed recommended dosage (see overdose warning)

Stop Use and Ask A Doctor If: (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. (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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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