Label: CODEINE PHOSPHATE AND GUAIFENESIN liquid

  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated September 24, 2018

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  • Active ingredients (in each teaspoonful (5 mL))

    Codeine phosphate USP 10 mg

    Guaifenesin USP 100 mg

  • Purpose

    Antitussive (Cough Suppressant)

    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • relieves your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves cough associated with the common cold
  • Warnings

  • ASK DOCTOR

    Ask your Doctor if:

    • you have a persistent or chronic cough, this may be a sign of a serious condition
    • you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • you have a cough that is accompanied by excessive phlegm (mucus)
    • you have chronic pulmonary disease or shortness of breath
    • giving to a child who is taking other drugs
  • WHEN USING

    When using this product

    • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age
    • may cause or aggravate constipation
  • STOP USE

    Stop use and ask a doctor if

    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever, rash, or persistent headache. These may be symptoms 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

    • do not exceed 6 doses in 24 hours

    Adults and children 12 years of age and over:

    2 tsp (10 mL) every 4 hours, or as directed by a doctor.

    Children 6 to under 12 years of age:

    1 tsp (5 mL) every 4 hours, or as directed by a doctor.

    Children under 6 years of age:

    Consult a doctor.
  • Other information

    Store at controlled room temperature 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    Cherry flavor, citric acid, ededate disodium, FD&C red #40, glycerin, maltodextrin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP. 

    20101 N.E 16TH PLACE 

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL

    NDC 17856-0208-1

    CODEINE PHOSPHATE-GUAIFENESIN

    ORAL SOL 10-100mg/mL CUP 72

    LABEL 1

  • INGREDIENTS AND APPEARANCE
    CODEINE PHOSPHATE AND GUAIFENESIN 
    codeine phosphate and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0208(NDC:54932-208)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0208-172 in 1 BOX, UNIT-DOSE09/24/2018
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/24/2018
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707repack(17856-0208) , relabel(17856-0208)
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