Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Benzoic Acid Fd&c Red No. 40 Glycerin Hydrochloric Acid Polyethylene Glycol, Unspecified Potassium Sorbate Propylene Glycol Water Sodium Hydroxide Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-10-15

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily relieves minor aches and pains due to:
- colds
- flu
- headache
- toothache
temporarily reduces fever

Purposes

Pain reliever/fever reducer

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

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Directions:

this product does not contain directions or complete warnings for adult use

do not take more than directed(see overdose warning)
find right dose in chart. If possible use weight to dose; otherwise, use age
if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor
do not take more than 5 doses in 24 hours, unless directed by a doctor
use only with enclosed pre-marked measuring syringe for accuracy. Do not use any other dosing device.

Age	Weight	Dosage
under 2 yrs	under 24 lbs	ask a doctor
2-3 yrs	24-35 lbs	5 mL

Other Information

store below 30°C (86°F)

Overdose Warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients

benzoic acid, FD&C red no. 40, flavor, glycerin, hydrochloric acid*, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium hydroxide*, sodium saccharin, sorbitol solution * contains one or more of these ingredients

Questions Or Comments?

1-800-455-7139(English/Spanish) weekdays

Keep Carton

Principal Display Panel

NDC 0135-0539-02

Panadol ^®

Infants’

ACETAMINOPHEN

160 mg per 5 mL

LIQUID

Pain Reliever

Fever Reducer

SEE NEW WARNINGS INFORMATION

Ages 2-3 years

Fast relief of fever and pain

Gentle on your stomach

Ibuprofen free
No sugar added
Aspirin free

artificial

raspberry flavor

Dosing Device Inside

l.85 fl oz (54.7 mL)

Tamper Evident Feature:Do not use if printed overwrap is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

GlaxoSmithKlineConsumer Healthcare, L.P.

Moon Township, PA 15108

Made in Canada

USING THE CONVENIENT DOSING DEVICE

Shake the bottle well. Push the dosing device firmly into the bottle’s neck.
Turnthe bottle upside down. Holding the device in place, gently pull the plunger out to draw the correct dose.
With the bottle in an upright position, remove the device from the plug and bottle by gently pullingit. Place the end of the device into the child’s mouth. Administer dose by pressing the plunger slowly.

After use, replace the cap. Washthe device in warm water and allow to dry.

PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies.

Keep Carton

102012XB (A134044)

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
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

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 relieves minor aches and pains due to:
- colds
- flu
- headache
- toothache
temporarily reduces fever

Purposes

Pain reliever/fever reducer

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

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Directions:

this product does not contain directions or complete warnings for adult use

do not take more than directed(see overdose warning)
find right dose in chart. If possible use weight to dose; otherwise, use age
if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor
do not take more than 5 doses in 24 hours, unless directed by a doctor
use only with enclosed pre-marked measuring syringe for accuracy. Do not use any other dosing device.

Age	Weight	Dosage
under 2 yrs	under 24 lbs	ask a doctor
2-3 yrs	24-35 lbs	5 mL

Other Information (Other information)

store below 30°C (86°F)

Overdose Warning: (Overdose warning:)

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients (Inactive ingredients)

benzoic acid, FD&C red no. 40, flavor, glycerin, hydrochloric acid*, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium hydroxide*, sodium saccharin, sorbitol solution * contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

1-800-455-7139(English/Spanish) weekdays

Keep Carton

Principal Display Panel

NDC 0135-0539-02

Panadol ^®

Infants’

ACETAMINOPHEN

160 mg per 5 mL

LIQUID

Pain Reliever

Fever Reducer

SEE NEW WARNINGS INFORMATION

Ages 2-3 years

Fast relief of fever and pain

Gentle on your stomach

Ibuprofen free
No sugar added
Aspirin free

artificial

raspberry flavor

Dosing Device Inside

l.85 fl oz (54.7 mL)

Tamper Evident Feature:Do not use if printed overwrap is missing or broken.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

GlaxoSmithKlineConsumer Healthcare, L.P.

Moon Township, PA 15108

Made in Canada

USING THE CONVENIENT DOSING DEVICE

Shake the bottle well. Push the dosing device firmly into the bottle’s neck.
Turnthe bottle upside down. Holding the device in place, gently pull the plunger out to draw the correct dose.
With the bottle in an upright position, remove the device from the plug and bottle by gently pullingit. Place the end of the device into the child’s mouth. Administer dose by pressing the plunger slowly.

After use, replace the cap. Washthe device in warm water and allow to dry.

PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies.

Keep Carton

102012XB (A134044)

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
redness or swelling is present
any new symptoms appear

These could be signs of a serious condition.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

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

[{"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: colds flu headache toothache temporarily reduces fever", "Purposes": "Pain reliever/fever reducer", "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 Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product", "Directions:": "this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning) find right dose in chart. If possible use weight to dose; otherwise, use age if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor do not take more than 5 doses in 24 hours, unless directed by a doctor use only with enclosed pre-marked measuring syringe for accuracy. Do not use any other dosing device. Age Weight Dosage under 2 yrs under 24 lbs ask a doctor 2-3 yrs 24-35 lbs 5 mL", "Other information": "store below 30°C (86°F)", "Overdose warning:": "Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Inactive ingredients": "benzoic acid, FD&C red no. 40, flavor, glycerin, hydrochloric acid*, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium hydroxide*, sodium saccharin, sorbitol solution * contains one or more of these ingredients", "Questions or comments?": "1-800-455-7139 (English/Spanish) weekdays Keep Carton", "Principal Display Panel": "NDC 0135-0539-02 Panadol ® Infants’ ACETAMINOPHEN 160 mg per 5 mL LIQUID Pain Reliever Fever Reducer SEE NEW WARNINGS INFORMATION Ages 2-3 years Fast relief of fever and pain Gentle on your stomach Ibuprofen free No sugar added Aspirin free artificial raspberry flavor Dosing Device Inside l.85 fl oz (54.7 mL) Tamper Evident Feature: Do not use if printed overwrap is missing or broken. READ AND KEEP CARTON FOR COMPLETE INFORMATION GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 Made in Canada ©2015 GSK All Rights Reserved. USING THE CONVENIENT DOSING DEVICE Shake the bottle well. Push the dosing device firmly into the bottle’s neck. Turn the bottle upside down. Holding the device in place, gently pull the plunger out to draw the correct dose. With the bottle in an upright position, remove the device from the plug and bottle by gently pulling it. Place the end of the device into the child’s mouth. Administer dose by pressing the plunger slowly. After use, replace the cap. Wash the device in warm water and allow to dry. PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies. Keep Carton 102012XB (A134044)", "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 redness or swelling is present any new symptoms appear These could be signs of a serious condition.", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information