Robafen™ Syrup

Robafen™ Syrup
SPL v1
SPL
SPL Set ID f69efbaf-a1ee-49c5-af2d-b1f3bb468d62
Route
ORAL
Published
Effective Date 2017-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Propylene Glycol Sodium Benzoate Saccharin Sodium Anhydrous Citric Acid Glycerin Menthol, Unspecified Form Corn Syrup Water Caramel Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-31

Description

Drug Facts

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the 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 51945-4

DRUG: ROBAFEN COUGH FORMULA

GENERIC: Guaifenesin

DOSAGE: SYRUP

ADMINSTRATION: ORAL

NDC: 61786-963-45

COLOR: brown

FLAVOR: MENTHOL

PACKAGING: 118 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • Guaifenesin 100mg in 5mL

INACTIVE INGREDIENT(S):

  • Corn Syrup
  • FD&C Red no. 40
  • Menthol, Unspecified Form
  • Caramel
  • Water
  • Glycerin
  • Sodium Benzoate
  • Propylene Glycol
  • Anhydrous Citric Acid
  • Saccharin Sodium

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
  • this product is not intended for use in children under 12 years of age
  • TSP = teaspoonful
adults and children 12 years and over 2 - 4 TSP every 4 hours
children under 12 years do not use
Other Information
  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments?

(800) 616-2471

Ask A Doctor Before Use If You Have
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough occurs with too much phlegm (mucus)
Active Ingredient (in Each 2 Tsp (10 Ml) )

Guaifenesin USP 200 mg


Structured Label Content

Uses

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 the 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 51945-4 (51945-4)

DRUG: ROBAFEN COUGH FORMULA

GENERIC: Guaifenesin

DOSAGE: SYRUP

ADMINSTRATION: ORAL

NDC: 61786-963-45

COLOR: brown

FLAVOR: MENTHOL

PACKAGING: 118 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • Guaifenesin 100mg in 5mL

INACTIVE INGREDIENT(S):

  • Corn Syrup
  • FD&C Red no. 40
  • Menthol, Unspecified Form
  • Caramel
  • Water
  • Glycerin
  • Sodium Benzoate
  • Propylene Glycol
  • Anhydrous Citric Acid
  • Saccharin Sodium

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
  • this product is not intended for use in children under 12 years of age
  • TSP = teaspoonful
adults and children 12 years and over 2 - 4 TSP every 4 hours
children under 12 years do not use
Other Information (Other information)
  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions Or Comments? (Questions or comments?)

(800) 616-2471

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough occurs with too much phlegm (mucus)
Active Ingredient (in Each 2 Tsp (10 Ml) ) (Active ingredient (in each 2 TSP (10 mL) ))

Guaifenesin USP 200 mg


Advanced Ingredient Data


Raw Label Data

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