CONTAC- acetaminophen and phenylephrine hydrochloride tablet
GlaxoSmithKline Consumer Healthcare LP

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.

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Active ingredients (in each caplet)

Acetaminophen 500mg

Phenylephrine hydrochloride 5mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms due to the common cold or flu:
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- headache
- stuffy nose
- sore throat
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 use more than directed

Stop use and ask a doctor if

you get nervous, dizzy or sleepless
pain or nasal congestion gets worse or last 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 25°C (77°F)

Inactive ingredients

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

Questions or comments?

call toll-free 1-800-245-1040 (English/Spanish) weekdays

TAMPER-EVIDENT PACKAGING FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.

Distributed by: GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in Ireland

CONTAC® is a registered trademark of the GlaxoSmithKline group of companies.

Retain outer carton for complete directions and warnings.

Principal Display Panel

CONTAC®

COLD +FLU

NASAL DECONGESTANT/PAIN RELIEVER-FEVER REDUCER

MAXIMUM STRENGTH

NON-DROWSY

RELIEF OF:

>Nasal Congestion >Phenylephrine

>Headaches, Sore Throat, Fever >Acetaminophen

See new warnings information.

NET CONTENTS:

24 CAPLETS

1000178XA

Contac Cold and Flu Carton

CONTAC
acetaminophen and phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0436
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POTASSIUM SORBATE
POVIDONE
SODIUM LAURYL SULFATE
STEARIC ACID
TALC

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	MS
Contains

Packaging
#	Item Code	Package Description
1	NDC:0135-0436-02	24 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2011	07/31/2013

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Registrant - Meda Consumer Healthcare Inc. (831410522)

Revised: 11/2011

Document Id: 01873e25-14b9-4f9f-b8c1-993081b1be11

Set id: 1b3db689-5878-48b6-8f22-550276cc2a7d

Version: 5

Effective Time: 20111109

GlaxoSmithKline Consumer Healthcare LP