Pediacare Infants Fever Reducer Cherry

Pediacare Infants Fever Reducer Cherry
SPL v3
SPL
SPL Set ID 8645c5e2-a936-499e-8c94-2172f2368d8c
Route
ORAL
Published
Effective Date 2010-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Butylparaben Citric Acid Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Propylparaben Water Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-27

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily:

  • reduces fever

  • relieves minor aches and pains due to:
    • the common cold

    • flu

    • sore throat

    • toothache

    • headache
Section 42229-5

Drug Facts

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.

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)
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.
Other Information

store between 20-25ºC (68-77ºF)

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.

Active Ingredients

(in each 0.8 mL )

Acetaminophen 80mg

Inactive Ingredients:

butyl paraben, citric acid, FD&C Red #40, 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

Ask A Doctor Before Use

if   your child has liver disease.

Principal Display Panel

NEW PediaCare® Infants

Fever Reducer Pain Reliever

Ludens® Cherry Taste!

1 FL OZ (30 mL)

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.

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

    • sore throat

    • toothache

    • headache
Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer

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.

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)
Do Not Use (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.
Other Information (Other information)

store between 20-25ºC (68-77ºF)

Overdose Warning: (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.

Active Ingredients

(in each 0.8 mL )

Acetaminophen 80mg

Inactive Ingredients: (Inactive ingredients:)

butyl paraben, citric acid, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum.

Questions Or Comments? (Questions or comments?)

call 1-888-474-3099

Distributed by:

Blacksmith Brands Inc.

200 White Plains Road

Tarrytown, NY 10591 USA

© 2010

Ask A Doctor Before Use (Ask a doctor before use)

if   your child has liver disease.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW PediaCare® Infants

Fever Reducer Pain Reliever

Ludens® Cherry Taste!

1 FL OZ (30 mL)

When Using This Product (When using this product)

do not exceed recommended dose.

(see overdose warning)

Stop Use and Ask A Doctor If (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.

Ask A Doctor Or Pharmacist Before Use (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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