major pharmaceuticals robafen™

major pharmaceuticals robafen™
SPL v5
SPL
SPL Set ID 65188fb6-1c0b-4e81-b0f7-af28d2b27b87
Route
oral
Published
Effective Date 2021-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (200 mg)
Inactive Ingredients
anhydrous citric acid caramel fd&c red no. 40 glycerin high fructose corn syrup propylene glycol water saccharin sodium sodium benzoate maltol menthol, unspecified form

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph final active Since 2018-08-13

Purpose

Expectorant

How Supplied

Product: 50090-4189 NDC: 50090-4189-0 473 mL in a BOTTLE

Description

Guaifenesin, USP 200 mg


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
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients

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

How Supplied

Product: 50090-4189

NDC: 50090-4189-0 473 mL in a BOTTLE

Description

Guaifenesin, USP 200 mg

Use

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

Guaifenesin
Questions Or Comments?

1-800-616-2471

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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).

Active Ingredient (in Each 10 Ml)

Guaifenesin, USP 200 mg

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

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)
  • store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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

How Supplied (HOW SUPPLIED)

Product: 50090-4189

NDC: 50090-4189-0 473 mL in a BOTTLE

Use

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

Guaifenesin
Questions Or Comments? (Questions or comments?)

1-800-616-2471

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

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

Guaifenesin, USP 200 mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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