FREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]

FREDS CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [REESE PHARMACEUTICAL CO]
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NDC 10956-761-01, 10956-761-50
Set ID 98e6d6ba-4164-4a14-b186-a5016c7e4c33
Category HUMAN OTC DRUG LABEL
Packager Reese Pharmaceutical Co
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredient - (per tablet) - Purpose

    Dextromethorphan Hydrobromide   20mg   Cough Suppressant
    Guaifenesin  400mg  Expectorant

  • ASK DOCTOR

    Ask doctor before use if you have

    persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

    cough is accompanied by excessive phlegm (mucous)

  • STOP USE

    Stop use and ask doctor if

    Symptoms are accompanied by fever, rash or persistent headache

    cough persists for more than 1 week or tends to recur

    A persistent cough may be a sign of a serious condition


  • DO NOT USE

    Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

    Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

    or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

    an MAIO, ask your doctor or pharmacist before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, In  ase of overdose, get medical help or contact a Poison Center immediately

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • INACTIVE INGREDIENT

    magnesium stearate, microcrystalline cellulose,
    May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium
    phosphate, maltodextrin, sodium starch glycolate, stearic acid

  • DOSAGE & ADMINISTRATION

    Directions        
    • Adults and children 12 years of age and over:    
    take 1 tablet every 4 hours as needed    
    • Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
    • Children under 6 years of age: consult a doctor    
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor
    Other information store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

  • INDICATIONS & USAGE

    Uses. temporarily relieves cough due to minor throat and bronchial irritation
    as may occur with a common cold • helps loosen phlegm (mucus) and thin
    bronchial secretions to rid the bronchial passageways of bothersome mucus
    • helps make coughs more productive

  • PRINCIPAL DISPLAY PANEL

    image of cartonEnter section text here

  • INGREDIENTS AND APPEARANCE
    FREDS CHEST CONGESTION RELIEF  DM
    dextromethorphan hydrobromide / guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-761
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code PH073
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-761-011 in 1 CARTON
    1NDC:10956-761-5050 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/30/2009
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reese Pharmaceutical Co004172052relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest557054835manufacture