Panadol Cold and Flu NonDrowsy

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0459

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Nasal decongestant

Uses
temporarily relieves these symptoms due to the common cold or flu:
nasal congestion
stuffy nose
sore throat
headache
sinus congestion and pressure
minor aches and pains
temporarily reduces fever

Warnings

Liver Warning: this product contains acetaminophen. Severe liver damage may occur if you take

more than 8 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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, ask a doctor promptly.

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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
liver disease
heart disease
thyroid disease
diabetes
high blood pressure
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if
you get nervous, dizzy or sleepless
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions
do not take more than directed (see overdose warning)
adults and children 12 years of age and over: take 2 caplets every 6 hours as needed
do not take more than 8 caplets in 24 hours
children under 12 years of age: ask a doctor

Other information
store below 30°C (86°F)

Inactive ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, pregelatinized starch, sodium lauryl sulfate, starch, stearic acid, talc

Questions or comments?

1-800-981-3511 (English/Spanish) weekdays

Tamper Evident Feature: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.

Read and keep carton for complete information

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Ireland

Principal Display Panel

NDC 0135-0459-02

PANADOL®

MAXIMUM STRENGTH

COLD + FLU

NON-DROWSY

ACETAMINOPHEN

Pain Reliever/Fever Reducer

PHENYLEPHRINE HCl

Nasal Decongestant

24 Caplets

©2011 GlaxoSmithKline

30108XC

PANADOL  COLD AND FLU NONDROWSY
acetaminophen and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0459
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POTASSIUM SORBATE 
POVIDONES 
STARCH, CORN 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (Caplet) Size18mm
FlavorImprint CodeMS
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0459-023 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
2NDC:0135-0459-0350 POUCH in 1 CARTON
2NDC:0135-0459-012 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/31/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 11/2013
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)