GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]

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GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]
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NDC 0121-0775-04, 0121-0775-08, 0121-0775-16, 0121-1550-00, 0121-1550-10, 0121-1775-00, 0121-1775-05, 0121-1775-10
Set ID 88d0994c-4270-4408-8837-bd97510b2118
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Associates, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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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 - 473 mL Bottle Label

    NDC 0121-0775-16

    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

    16 fl oz (473 mL)

    pai
    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    Principal Display Panel - 473 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

    Delivers 10 mL

    NDC 0121-1550-10

    G UAIFENESIN AND

    C ODEINE P HOSPHATE

    O RAL S OLUTION USP

    CV

    200 mg/20 mg per 10 mL

    Expectorant / Cough Suppressant

    Alcohol Free / Sugar Free

    FOR INSTITUTIONAL USE ONLY

    PHARMACEUTICAL ASSOCIATES, INC.

    GREENVILLE, SC 29605

    SEE INSERT

    A17751001

    PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label - 1775

    Delivers 10 mL

    NDC 0121-1775-10

    G UAIFENESIN AND
    C ODEINE P HOSPHATE
    O RAL S OLUTION USP
    CV

    200 mg/20 mg per 10 mL

    Expectorant / Cough Suppressant
    Alcohol Free / Sugar Free

    FOR INSTITUTIONAL USE ONLY

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605
    SEE INSERT

    A17751000

    Principal Display Panel - 10 mL Unit Dose Cup Label - 1775
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0121-0775-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
    2NDC:0121-0775-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
    3NDC:0121-0775-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2006
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1775
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    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)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1775-0010 in 1 CASE10/01/2006
    110 in 1 TRAY
    1NDC:0121-1775-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-1775-1010 in 1 CASE10/01/2006
    210 in 1 TRAY
    210 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 finalpart34110/01/2006
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1550
    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:0121-1550-0010 in 1 CASE10/01/2006
    110 in 1 TRAY
    1NDC:0121-1550-1010 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 finalpart34110/01/2006
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0775, 0121-1775, 0121-1550)
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