ROBITUSSIN 12 HOUR COUGH RELIEF- dextromethorphan polistirex suspension, extended release

Robitussin 12 Hour Cough Relief by

Drug Labeling and Warnings

Robitussin 12 Hour Cough Relief by is a Otc medication manufactured, distributed, or labeled by Richmond Division of Wyeth. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 - 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 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 - 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 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 - 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 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 - 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 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

INGREDIENTS AND APPEARANCE

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 - Wyeth Consumer Healthcare LLC (828831730)