SPL v10
SPL
SPL Set ID 75bc7827-4439-e6a8-a65c-7154d5592e58
Route
ORAL
Published
Effective Date 2020-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (7.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-01-01

Description

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan HBr, USP 15 mg

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

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, or emphysema
Section 50570-1

Do not useif 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.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • do not take more than 4 doses in any 24-hour period
age dose

children under 4 years

do not use

children 4 to under 6 years

5 ml every 6 - 8 hours

children 6 to

under 12 years

10 ml

every 6 to 8 hours

adults and children

12 years and older

20 ml

every 6 to 8 hours

Other Information
  • each 10 ml contains:sodium 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate

Questions Or Comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by:

Pfizer, Madison, NJ 07940 USA

For most recent product information, visit

www.robitussin.com

Principal Display Panel

NEW

Dosing

Information

Children's

Robitussin ®

NOW FOR AGES 4 & OVER

Cough

Long-Acting

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

✓ Cough Up to 8 Hours

Alcohol-Free

fruit

punch

flavor

4 FL OZ

(118 ml)

Active Ingredient (in Each 10 Ml)

Dextromethorphan HBr, USP 15 mg


Structured Label Content

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

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, or emphysema
Section 50570-1 (50570-1)

Do not useif 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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Cough suppressant

Directions
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • do not take more than 4 doses in any 24-hour period
age dose

children under 4 years

do not use

children 4 to under 6 years

5 ml every 6 - 8 hours

children 6 to

under 12 years

10 ml

every 6 to 8 hours

adults and children

12 years and older

20 ml

every 6 to 8 hours

Other Information (Other information)
  • each 10 ml contains:sodium 11 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate

Questions Or Comments? (Questions or comments?)

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by:

Pfizer, Madison, NJ 07940 USA

For most recent product information, visit

www.robitussin.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

Dosing

Information

Children's

Robitussin ®

NOW FOR AGES 4 & OVER

Cough

Long-Acting

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

✓ Cough Up to 8 Hours

Alcohol-Free

fruit

punch

flavor

4 FL OZ

(118 ml)

Active Ingredient (in Each 10 Ml) (Active ingredient (in each 10 ml))

Dextromethorphan HBr, USP 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)