Home > Drugs A-Z > Head Congestion Cold Relief

Head Congestion Cold Relief (WOONSOCKET PRESCRIPTION CENTER, INCORPORATED)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BLISTER PACK in 1 CARTON (59779-470-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK Label Information

Complete Head Congestion Cold Relief Information

  • Drug Facts


  • Active ingredients

    (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg


  • Purpose

    Pain reliever

    Cough suppressant

    Nasal decongestant


  • Uses

    • temporarily relieves theses common cold symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • helps clear nasal passages

  • 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 vommiting, 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. 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

    • diabetes
    • thyroid disease
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • heart disease
    • liver disease
    • cough that occurs with too much phlegm (mucus)

  • 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

    • 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, croscarmellose sodium, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, sucralose, talc, titanium dioxide


  • Questions or comments?

    Call 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 Daytime*

    See New Warnings

    Information

    HEAD CONGESTION

    COLD RELIEF

    PAIN RELIEVER, NASAL DECONGESTANT,

    COUGH SUPPRESSANT

    DAYTIME

    NON-DROWSY

    CONTAINS 3 MEDICINES

    Headache Pain -

    - Acetaminophen

    Sore Throat -

    Nasal Congestion - Phenylephrine HCl

    Coughing - Dextromethorphan HBr

    12 COOL ICE® CAPLETS

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

    50844             REV1009A47002

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2010 CVS/pharmacy

    www.cvs.com               1-800-shop-CVS

    Product Label

  • INGREDIENTS AND APPEARANCE
    HEAD CONGESTION COLD RELIEF  
    acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-470
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 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)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    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 WHITE Score no score
    Shape CAPSULE Size 17mm
    Flavor MENTHOL (Cool Flavored) Imprint Code 44;470
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-470-01 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 06/11/2006
    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