HEAD CONGESTION COLD RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Head Congestion Cold Relief by

Drug Labeling and Warnings

Head Congestion Cold Relief by is a Otc medication manufactured, distributed, or labeled by WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, L.N.K. International, Inc., L.N.K. International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these common cold symptoms:
• minor aches and pains
• headache
• cough
• sneezing and runny nose
• nasal congestion
• sinus congestion and pressure
• sore throat
• helps clear nasal passages
• relieves cough to help you sleep

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 12 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, consult 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, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• liver disease
• diabetes
• heart disease
• high blood pressure
• glaucoma
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts.

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 (overdose) may cause liver damage. 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 and over
• take 2 caplets every 4 hours
• swallow whole - do not crush, chew, or dissolve
• do not take more than 12 caplets in 24 hours
• children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, FD&C blue #1, FD&C blue #2, flavor, magnesium stearate, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active

 ingredients of Tylenol® Cold

Head Congestion Nighttime*

See New Warnings

Information

HEAD CONGESTION

COLD RELIEF

PAIN RELIEVER, NASAL DECONGESTANT,

COUGH SUPPRESSANT, ANTIHISTAMINE

NIGHTTIME

TO LET YOU SLEEP

CONTAINS 4 MEDICINES

Headache Pain -

- Acetaminophen

Sore Throat -

Nasal Congestion - Phenylephrine HCl

Coughing - Dextromethorphan HBr

Runny Nose - Chlorpheniramine Maleate

12  COOL ICE® CAPLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844                 REV1009A47302

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

INGREDIENTS AND APPEARANCE

HEAD CONGESTION COLD RELIEF  
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-473
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	2 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
Starch, Corn (UNII: O8232NY3SJ)
Fd&c Blue No. 1 (UNII: H3R47K3TBD)
Fd&c Blue No. 2 (UNII: L06K8R7DQK)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polyethylene Glycol (UNII: 3WJQ0SDW1A)
Polyvinyl Alcohol (UNII: 532B59J990)
Povidone (UNII: FZ989GH94E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Stearic Acid (UNII: 4ELV7Z65AP)
Sucralose (UNII: 96K6UQ3ZD4)
Talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor	MENTHOL (Cool Ice)	Imprint Code	44;473
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-473-01	1 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/21/2005

Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)

Registrant - L.N.K. International, Inc. (832867837)

Establishment
Name	Address	ID/FEI	Business Operations
L.N.K. International, Inc		832867894	MANUFACTURE