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

Purpose

Expectorant

Description

Drug Facts


Medication Information

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
  • 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

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.

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

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

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.

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)