GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]

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GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]
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NDC 0121-0744-04, 0121-0744-08, 0121-0744-16, 0121-1488-00, 0121-1488-10, 0121-1744-00, 0121-1744-05, 0121-1744-10, 0121-1744-15, 0121-2232-00, 0121-2232-15
Set ID c2e53fb5-2798-47c8-9285-d1077d46e629
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Associates, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • PURPOSE

    Expectorant
    SUGAR FREE / ALCOHOL FREE

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains:
    Guaifenesin 100 mg

  • Inactive Ingredients

    Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate.

    Sodium Content: 4 mg/5 mL

  • USES

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • WARNINGS

    Ask a doctor before use if you have

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

    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.
    • you are hypersensitive to any of the ingredients.

    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.

  • Professional Note

    Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

  • DIRECTIONS

    Follow dosage below or use as directed by a physician.

    • do not take more than 6 doses in any 24-hour period.
    agedose
    adults and children 12 years and over10 to 20 mL
    (2 to 4 teaspoonfuls)
    every 4 hours
    children 6 years to under 12 years5 to 10 mL
    (1 to 2 teaspoonfuls)
    every 4 hours
    children 2 to under 6 years of age2.5 to 5 mL
    (½ to 1 teaspoonful)
    every 4 hours
    children under 2 years of ageconsult a physician
  • HOW SUPPLIED

    Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms:

    NDC 0121-0744-04: 4 fl oz (120 mL) bottle
    NDC 0121-0744-08: 8 fl oz (237 mL) bottle
    NDC 0121-0744-16: 16 fl oz (473 mL) bottle

    NDC 0121-1744-05: 5 mL unit dose cup
    NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-1488-10: 10 mL unit dose cup
    NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each.

    NDC 0121-2232-15: 15 mL unit dose cup
    NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.

  • STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0121-0744-16

    Quality ®
    Value

    Guaifenesin Oral Solution USP

    100 mg/5 mL

    EXPECTORANT

    Compare to the
    active ingredient in
    *Robitussin®

    SUGAR FREE/ALCOHOL FREE
    LOOSENS AND RELIEVES
    CHEST CONGESTION

    16 fl oz (473 mL)

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    Delivers 5 mL

    NDC 0121-1744-05

    G UAIFENESIN O RAL S OLUTION USP

    100 mg/5 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

    Delivers 10 mL

    NDC 0121-1488-10

    G UAIFENESIN O RAL S OLUTION USP

    200 mg/10 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

  • PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

    Delivers 15 mL

    NDC 0121-2232-15

    G UAIFENESIN O RAL S OLUTION USP

    300 mg/15 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 15 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0744-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2002
    2NDC:0121-0744-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2002
    3NDC:0121-0744-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1744-0010 in 1 CASE09/01/2002
    110 in 1 TRAY
    1NDC:0121-1744-055 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 finalpart34109/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1488-0010 in 1 CASE09/01/2002
    110 in 1 TRAY
    1NDC:0121-1488-1010 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 finalpart34109/01/2002
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-2232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-2232-0010 in 1 CASE09/01/2002
    110 in 1 TRAY
    1NDC:0121-2232-1515 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 finalpart34109/01/2002
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0744, 0121-1744, 0121-1488, 0121-2232)
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