PANADOL- acetaminophen suspension

PANADOL by

Drug Labeling and Warnings

PANADOL by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

Uses

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

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

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

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.

Keep out of reach of children.

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.

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)

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)

INGREDIENTS AND APPEARANCE

PANADOL 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0539
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (light red)	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0539-02	1 in 1 CARTON	10/15/2012
1		54.7 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/15/2012

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)