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Childrens Robitussin 12 Hour Cough Relief

Dosage form: suspension, extended release
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 30mg in 5mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8725

Children's 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

  • 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

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

  • 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 over10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of agedo not use

Other information

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

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 © 2016 Pfizer Inc.

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label - Orange

Children's
Robitussin®

For adults & children
AGES 4 & OVER

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

NEW!

Children's
Robitussin®

For adults & children
AGES 4 & OVER

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 Label - Grape

Children's
Robitussin®

For adults & children
AGES 4 & OVER

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

NEW!

Children's
Robitussin®

For adults & children
AGES 4 & OVER

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

CHILDRENS ROBITUSSIN 12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8725
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLISTIREX 
D&C RED NO. 30 
D&C YELLOW NO. 10 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ACETATE 
POVIDONES 
PROPYLPARABEN 
SODIUM METABISULFITE 
SODIUM POLYSTYRENE SULFONATE 
SUCROSE 
TARTARIC ACID 
TRAGACANTH 
TRIACETIN 
WATER 
XANTHAN GUM 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8725-101 BOTTLE in 1 CARTON
189 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113507/05/2016
CHILDRENS ROBITUSSIN 12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8726
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLISTIREX 
D&C RED NO. 30 
FD&C BLUE NO. 1 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ACETATE 
POVIDONES 
PROPYLPARABEN 
SODIUM METABISULFITE 
SODIUM POLYSTYRENE SULFONATE 
SUCROSE 
TARTARIC ACID 
TRAGACANTH 
TRIACETIN 
WATER 
XANTHAN GUM 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8726-101 BOTTLE in 1 CARTON
189 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113507/05/2016
Labeler - Richmond Division of Wyeth (829390835)

 
Richmond Division of Wyeth

Medically reviewed on Aug 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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