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Panadol Cold and Flu NonDrowsy

Medically reviewed by Drugs.com. Last updated on Dec 30, 2020.

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0607

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 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 4,000 mg of acetaminophen 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

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.

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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have
liver disease
diabetes
heart disease
high blood pressure
thyroid disease
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 recommend 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

These could be signs of a serious condition.

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 4 hours, while symptoms persist or as directed by a doctor
do not take more than 12 caplets in 24 hours, unless directed by a doctor
children under 12 years of age: ask a doctor
swallow whole – do not crush, chew or dissolve

Other information
store below 25°C (77°F)

Inactive ingredients

acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Principal Display Panel

NDC 0135-0607-02

Panadol®

COLD+FLU

NON-DROWSY

ACETAMINOPHEN

Pain Reliever/Fever Reducer

PHENYLEPHRINE HCl

Nasal Decongestant

NEW FORMULA AND DIRECTIONS

24 CAPLETS

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

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

30108XE

PANADOL  COLD AND FLU NONDROWSY
acetaminophen and phenyleprine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0607
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARNAUBA WAX 
CROSPOVIDONE (15 MPA.S AT 5%) 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
LECITHIN, SOYBEAN 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (caplet) Size16mm
FlavorVANILLAImprint CodeCF
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0607-0350 PACKET in 1 CARTON
1NDC:0135-0607-012 TABLET, FILM COATED in 1 PACKET
2NDC:0135-0607-023 BLISTER PACK in 1 CARTON
28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.