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 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients in each 5 mL (teaspoonful)Purposes

    Codeine Phosphate, USP 10 mg

    Cough Suppressant

    Guaifenesin, USP 100 mg

    Expectorant
  • 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 over

    10 mL (2 teaspoonfuls)

    children 6 to under 12 years of age

    5 mL (1 teaspoonful)

    children under 6 years of age

    Consult 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 - 118 mL Bottle Label

    NDC 68788-8361-1

    Guaifenesin and Codeine
    Phosphate Oral Solution USP
    CV

    100 mg/10 mg per 5 mL

    Expectorant / Cough Suppressant

    Alcohol Free / Sugar Free

    Each teaspoonful (5 mL) contains:
    Guaifenesin, USP 100 mg
    Codeine Phosphate, USP 10 mg

    Dispense in a tight, light-resistant
    container with a child-resistant closure.

    DO NOT ACCEPT IF SEAL
    AROUND CAP IS BROKEN OR MISSING

    118mL

    pai
    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    Relabeled By: Preferred Pharmaceuticals Inc.

    Guaifenesin Codeine Oral Sol 10-100mg5mL CV
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8361(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
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8361-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8361)
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