Robitussin®

Robitussin®
SPL v3
SPL
SPL Set ID 259c8b69-c625-4146-b888-34ef43b8385f
Route
ORAL
Published
Effective Date 2015-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
Anhydrous Citric Acid Caramel Dextrose Fd&c Red No. 40 High Fructose Corn Syrup Menthol, Unspecified Form Propylene Glycol, (r)- Saccharin Sodium Sodium Benzoate Water Glycerin

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-07-18

Description

Drug Facts

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Drug Facts

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5

Drug Facts

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 if cough 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, chronic bronchitis, or emphysema
Section 53414-9

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

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml=milliliter
  • this adult product is not intended for use in children under 12 years of age
age dose
adults and children 12 years and over 10-20 ml every 4 hours
children under 12 years do not use
Other Information
  • each 10 ml contains: sodium 4 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • alcohol-free
Inactive Ingredients

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

Questions Or Comments?

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

Active Ingredient (in Each 10 Ml)

Guaifenesin, USP 200 mg

Principal Display Panel 118 Ml Bottle Label

ADULT

Robitussin®

Mucus + Chest Congestion

GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

Principal Display Panel 118 Ml Bottle Carton

ADULT

Robitussin®

Mucus + Chest

Congestion

GUAIFENESIN (Expectorant)

Relieves:

  • Mucus
  • Chest Congestion

Alcohol-Free

ORIGINAL

For Ages 12 & Over

4 FL OZ

(118 ml)


Structured Label Content

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5 (42229-5)

Drug Facts

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 if cough 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, chronic bronchitis, or emphysema
Section 53414-9 (53414-9)

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

Purpose

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml=milliliter
  • this adult product is not intended for use in children under 12 years of age
age dose
adults and children 12 years and over 10-20 ml every 4 hours
children under 12 years do not use
Other Information (Other information)
  • each 10 ml contains: sodium 4 mg
  • store at 20-25°C (68-77°F). Do not refrigerate
  • alcohol-free
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

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

Guaifenesin, USP 200 mg

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

ADULT

Robitussin®

Mucus + Chest Congestion

GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

ADULT

Robitussin®

Mucus + Chest

Congestion

GUAIFENESIN (Expectorant)

Relieves:

  • Mucus
  • Chest Congestion

Alcohol-Free

ORIGINAL

For Ages 12 & Over

4 FL OZ

(118 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)