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NDC 00904-6763-20 robafen 200 mg/10mL Details

robafen 200 mg/10mL

robafen is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is GUAIFENESIN.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 00904-6763-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00904-6763
Product ID	0904-6763_2c946d4b-760f-49e7-a3ec-367b24fbeb22
Associated GPIs	43200010001210 43200010000910
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	robafen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/10mL
Substance Name	GUAIFENESIN
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-6763-20 (00904676320)

Pricing Information
NDC Package Code	0904-6763-20
Billing NDC	00904676320
Package	1 BOTTLE in 1 CARTON (0904-6763-20) / 118 mL in 1 BOTTLE
Marketing Start Date	2018-08-13
NDC Exclude Flag	N
Price Per Unit	0.02001
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	ROBAFEN 200 MG/10 ML SYRUP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 25f18a65-6b39-4e0a-8bae-79d2eac5abb1 Details

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

Principal Display Panel

ROBAFEN™

Congestion Formula

Guaifenesin, USP 200 mg

Expectorant

Relieves:

Mucus

Chest Congestion

Cherry Flavor

Dosing Cup Included

Alcohol Free

For Adults Ages 12 and Over

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ROBAFEN

guaifenesin solution

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6763-20	1 in 1 CARTON	08/13/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0904-6763-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2018	02/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/13/2018

Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2021

Document Id: 2c946d4b-760f-49e7-a3ec-367b24fbeb22

Set id: 25f18a65-6b39-4e0a-8bae-79d2eac5abb1

Version: 5

Effective Time: 20211019