GUAIFENESIN AND CODEINE PHOSPHATE SF (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [PHYSICIANS TOTAL CARE, INC.]

GUAIFENESIN AND CODEINE PHOSPHATE SF (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-4768-0, 54868-4768-1
Set ID 5b426e6a-b892-4ed9-afee-06d5a8af6320
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredients (in each 5 mL = 1 tsp)

    Codeine phosphate, USP 10 mg

    Guaifenesin, USP 100 mg

  • Purpose

    Cough suppressant

    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • calms the cough control center and relieves coughing
  • Warnings

  • DO NOT USE

    Do not use

    • in a child under 2 years of age
    • if you or your child has a chronic pulmonary disease or shortness of breath
    • if your child is taking other drugs, unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use if you have

    • cough that occurs with excessive phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • WHEN USING

    When using this product constipation may occur or be aggravated

  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 hours
    • do not take more than 6 doses in any 24-hour period

    adults and children 12 years and over

    take 10 mL (2 tsp)

    children 6 years to under 12 years

    take 5 mL (1 tsp)

    children 2 years to under 6 years

    consult a doctor

    children under 2 years

    do not use

    Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

  • Other information

    store at 15° to 30°C (59° to 86°F)

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • Inactive ingredients

    alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 11/09 R6 8081202 1075



    Additional barcode labeling applied by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146

  • PRINCIPAL DISPLAY PANEL

    image of package label

    Guaifenesin and Codeine Phosphate Syrup SF
    100/10 mg   (118 mL)
    NDC 54868-4768-0
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE  SF
    guaifenesin and codeine phosphate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4768(NDC:0603-1075)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARAMEL (UNII: T9D99G2B1R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-4768-0118 mL in 1 BOTTLE, PLASTIC
    2NDC:54868-4768-1473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/26/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel