Major Pharmaceuticals Robafen ™ Drug Facts

robafen by

Drug Labeling and Warnings

robafen by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROBAFEN- guaifenesin solution 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Major Pharmaceuticals Robafen ™ Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Use

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

Warnings

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

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).

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, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-800-616-2471

DRUG: robafen

GENERIC: Guaifenesin

DOSAGE: SOLUTION

ADMINSTRATION: ORAL

NDC: 70518-2782-0

NDC: 70518-2782-1

NDC: 70518-2782-2

NDC: 70518-2782-3

NDC: 70518-2782-4

COLOR: red

FLAVOR: CHERRY

PACKAGING: 20 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

PACKAGING: 118 mL in 1 BOTTLE TYPE 0

OUTER PACKAGING: 1 in 1 CARTON

PACKAGING; 10 in 1 BOX

PACKAGING: 20 mL in 1 CUP, UNIT DOSE

ACTIVE INGREDIENT(S):

• GUAIFENESIN 200mg in 10mL

INACTIVE INGREDIENT(S):

• ANHYDROUS CITRIC ACID
• CARAMEL
• FD&C RED NO. 40
• GLYCERIN
• HIGH FRUCTOSE CORN SYRUP
• PROPYLENE GLYCOL
• WATER
• SACCHARIN SODIUM
• SODIUM BENZOATE
• MENTHOL, UNSPECIFIED FORM

ROBAFEN 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-2782(NDC: 0904-6763)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Product Characteristics
Color	red (dark)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-2782-0	10 in 1 BOX	11/02/2020	05/09/2023
1	NDC: 70518-2782-1	20 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 70518-2782-2	1 in 1 CARTON	09/08/2021	05/09/2023
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 70518-2782-3	10 in 1 BOX	02/26/2023	05/09/2023
3	NDC: 70518-2782-4	20 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/02/2020	05/09/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2023

Document Id: f82022a7-f7c8-fe9a-e053-6394a90ae7f8

34390-5

Set id: f18ae8f4-55ba-4604-9023-3256ea32f7e9

Version: 4

Effective Time: 20230330