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Head Congestion Cold Relief by WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC Code: 59779-473

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 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

HEAD CONGESTION COLD RELIEF  
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-473
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate2 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn 
Fd&c Blue No. 1 
Fd&c Blue No. 2 
Magnesium Stearate 
Cellulose, Microcrystalline 
Polyethylene Glycol 
Polyvinyl Alcohol 
Povidone 
Silicon Dioxide 
Stearic Acid 
Sucralose 
Talc 
Titanium Dioxide 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize17mm
FlavorMENTHOL (Cool Ice) Imprint Code44;473
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-473-011 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/21/2005
Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIOperations
L.N.K. International, Inc832867894MANUFACTURE

 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

← See all Head Congestion Cold Relief brands

Medically reviewed on Aug 30, 2018

Further information

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

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