ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]

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ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]
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NDC 0031-8655-10, 0031-8753-03, 0031-8754-15, 0031-8755-15
Set ID 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number ANDA091135
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  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)

    Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

  • PURPOSE

    Purpose

    Cough suppressant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves

    •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    •
    the impulse to cough to help you get to sleep
  • WARNINGS

    Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Allergy Alert

    Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if

    •
    side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    •
    cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

    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 1-800-222-1222.

  • DOSAGE & ADMINISTRATION

    Directions

    •
    shake bottle well before use
    •
    measure only with dosing cup provided. Do not use dosing cup with other products
    •
    dose as follows or as directed by doctor
    •
    mL = milliliter

    adults and children 12 years of age and over

    10 mL every 12 hours, not to exceed 20 mL in 24 hours

    children 6 to under 12 years of age

    5 mL every 12 hours, not to exceed 10 mL in 24 hours

    children 4 to under 6 years of age

    2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

    children under 4 years of age

    do not use
  • STORAGE AND HANDLING

    Other information

    •
    each 5 mL contains: sodium 5 mg
    •
    store at 20-25°C (68-77°F)
    •
    dosing cup provided
  • INACTIVE INGREDIENT

    Inactive ingredients (Grape flavor)

    D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

  • INACTIVE INGREDIENT

    Inactive ingredients (Orange flavor)

    D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

  • QUESTIONS

    Questions?

    call weekdays from 9 AM to 5 PM EST at 1-800-762-4675.
    You may also report side effects to this number.

    For most recent product information, visit www.robitussin.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL

    Robitussin®

    EXTENDED-RELEASE
    12 Hour
    Cough Relief

    DEXTROMETHORPHAN POLISTIREX EXTENDED-
    RELEASE ORAL SUSPENSION (Cough Suppressant)

    12 Hour
    Cough Relief

    DAY or NIGHT

    Orange
    Flavored Liquid

    Alcohol-Free

    3 FL OZ (89 mL)

    Contains sodium metabisulfite, a sulfite
    that may cause allergic-type reactions

    Robitussin 12 HR Orange 3 FL OZ(89 mL)
  • PRINCIPAL DISPLAY PANEL

    NEW SIZE!

    Robitussin®

    EXTENDED-RELEASE
    12 Hour
    Cough Relief

    DEXTROMETHORPHAN POLISTIREX EXTENDED-
    RELEASE ORAL SUSPENSION (Cough Suppressant)

    12 Hour
    Cough Relief

    DAY or NIGHT

    Orange
    Flavored Liquid

    Alcohol-Free

    5 FL OZ
    (148 mL)

    Contains sodium metabisulfite, a sulfite
    that may cause allergic-type reactions

    Robitussin 12 HR Orange 5 FL OZ (148 mL)
  • PRINCIPAL DISPLAY PANEL

    Robitussin®

    EXTENDED-RELEASE
    12 Hour
    Cough Relief

    DEXTROMETHORPHAN POLISTIREX EXTENDED-
    RELEASE ORAL SUSPENSION (Cough Suppressant)

    12 Hour
    Cough Relief

    DAY or NIGHT

    Grape
    Flavored Liquid

    Alcohol-Free

    3 FL OZ (89 mL)

    Contains sodium metabisulfite, a sulfite
    that may cause allergic-type reactions

    Robitussin 12 HR Grape 3 FL OZ (89 mL)
  • PRINCIPAL DISPLAY PANEL

    NEW SIZE!

    Robitussin®

    EXTENDED-RELEASE
    12 Hour
    Cough Relief

    DEXTROMETHORPHAN POLISTIREX EXTENDED-
    RELEASE ORAL SUSPENSION (Cough Suppressant)

    12 Hour
    Cough Relief

    DAY or NIGHT

    Grape
    Flavored Liquid

    Alcohol-Free

    5 FL OZ
    (148 mL)

    Contains sodium metabisulfite, a sulfite
    that may cause allergic-type reactions

    Robitussin 12 HR Grape 5 FL OZ (148 mL)
  • INGREDIENTS AND APPEARANCE
    ROBITUSSIN 12 HOUR COUGH RELIEF 
    dextromethorphan polistirex suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8655
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLISTIREX (UNII: 5H9W9GTW27)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    TRAGACANTH (UNII: 2944357O2O)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8655-101 in 1 CARTON07/01/2015
    189 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113507/01/2015
    ROBITUSSIN 12 HOUR COUGH RELIEF 
    dextromethorphan polistirex suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8754
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLISTIREX (UNII: 5H9W9GTW27)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    TRAGACANTH (UNII: 2944357O2O)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8754-151 in 1 CARTON07/05/2016
    1148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113507/05/2016
    ROBITUSSIN 12 HOUR COUGH RELIEF 
    dextromethorphan polistirex suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8753
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLISTIREX (UNII: 5H9W9GTW27)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    TRAGACANTH (UNII: 2944357O2O)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8753-031 in 1 CARTON07/01/2015
    189 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113507/01/2015
    ROBITUSSIN 12 HOUR COUGH RELIEF 
    dextromethorphan polistirex suspension, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8755
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLISTIREX (UNII: 5H9W9GTW27)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    SUCROSE (UNII: C151H8M554)  
    TARTARIC ACID (UNII: W4888I119H)  
    TRAGACANTH (UNII: 2944357O2O)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-8755-151 in 1 CARTON07/05/2016
    1148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09113507/05/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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