Label: GUAIFENESIN AND CODEINE PHOSPHATE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: OTC monograph final

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 February 10, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients in each 5 mL (teaspoonful)Purposes
    Codeine Phosphate, USP 10 mgCough Suppressant
    Guaifenesin, USP 100 mgExpectorant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • Warnings

    Do not use

    • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

    Ask a doctor before use if you have

    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
    • may cause or aggravate constipation

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

    Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    • Use of codeine-containing preparation is not recommended for children under 2 years of age.
  • Directions

    • take every 4 hours
    • do not exceed 6 doses in 24 hours
    • 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 can result in serious side effects for a child
    adults and children 12 years and over10 mL (2 teaspoonfuls)
    children 6 to under 12 years of age5 mL (1 teaspoonful)
    children under 6 years of ageConsult a doctor
  • Other information

    • Sodium Content: 5 mg/5 mL
    • Tamper evident: Do not use if seal under cap is broken or missing
    • Keep container closed and store away from heat
    • Store at 20°- 25°C (68°-77°F)
  • Inactive ingredients

    Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

  • Questions or comments?

    Call 1-800-845-8210 or visit paipharma.com

    Serious side effects associated with use of this product may be reported to this number.

  • PRINCIPAL DISPLAY PANEL -

    PDP

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-1350(NDC:0121-0775)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-1350-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2006
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-1350)
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