ROBITUSSIN 12 HOUR COUGH RELIEF- dextromethorphan polistirex suspension, extended release 
Richmond Division of Wyeth

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Robitussin® 12 Hour Cough Relief

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Purpose

Cough suppressant

Uses

temporarily relieves

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.

Directions

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

Other information

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 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?

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

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label - Orange

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE
ORAL SUSPENSION (Cough Suppressant)

DAY or NIGHT

Alcohol-Free

Orange
Flavored Liquid

3 FL OZ (89 mL)

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

Principal Display Panel - 89 mL Bottle Label - Orange

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton - Orange

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

Principal Display Panel - 89 mL Bottle Carton - Orange

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label - Orange

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE
ORAL SUSPENSION (Cough Suppressant)

DAY or NIGHT

Alcohol-Free

Orange
Flavored Liquid

5 FL OZ (148 mL)

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

Principal Display Panel - 148 mL Bottle Label - Orange

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton - Orange

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

Principal Display Panel - 148 mL Bottle Carton - Orange

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label - Grape

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE
ORAL SUSPENSION (Cough Suppressant)

DAY or NIGHT

Alcohol-Free

Grape
Flavored Liquid

3 FL OZ (89 mL)

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

Principal Display Panel - 89 mL Bottle Label - Grape

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton - Grape

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

Principal Display Panel - 89 mL Bottle Carton - Grape

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label - Grape

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE
ORAL SUSPENSION (Cough Suppressant)

DAY or NIGHT

Alcohol-Free

Grape
Flavored Liquid

5 FL OZ (148 mL)

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

Principal Display Panel - 148 mL Bottle Label - Grape

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton - Grape

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

Principal Display Panel - 148 mL Bottle Carton - Grape
ROBITUSSIN 12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8655
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color ORANGE Score     
Shape Size
Flavor ORANGE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0031-8655-10 1 in 1 CARTON 07/01/2015
1 89 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 07/01/2015
ROBITUSSIN 12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8754
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color ORANGE Score     
Shape Size
Flavor ORANGE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0031-8754-15 1 in 1 CARTON 07/05/2016
1 148 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 07/05/2016
ROBITUSSIN 12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8753
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0031-8753-03 1 in 1 CARTON 07/01/2015
1 89 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 07/01/2015
ROBITUSSIN 12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8755
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0031-8755-15 1 in 1 CARTON 07/05/2016
1 148 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 07/05/2016
Labeler - Richmond Division of Wyeth (829390835)

Revised: 8/2016
Document Id: adf0f894-ec19-49ea-8ee4-061e14ab22bd
Set id: 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
Version: 3
Effective Time: 20160818
 
Richmond Division of Wyeth