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NDC 70518-2782-02 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 REMEDYREPACK INC.. 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: 70518-2782-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	70518-2782
Product ID	70518-2782_dcb24374-8093-8380-e053-2995a90afa35
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	REMEDYREPACK INC.
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2782-02 (70518278202)

Pricing Information	N/A
NDC Package Code	70518-2782-2
Billing NDC	70518278202
Package	1 BOTTLE in 1 CARTON (70518-2782-2) / 118 mL in 1 BOTTLE
Marketing Start Date	2021-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f18ae8f4-55ba-4604-9023-3256ea32f7e9 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

DRUG: robafen

GENERIC: Guaifenesin

DOSAGE: SOLUTION

ADMINSTRATION: ORAL

NDC: 70518-2782-0

NDC: 70518-2782-1

NDC: 70518-2782-2

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

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

INGREDIENTS AND APPEARANCE

ROBAFEN

guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2782(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
Packaging
1	NDC:70518-2782-0	10 in 1 BOX	11/02/2020
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
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/02/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2022

Document Id: dcb24374-8093-8380-e053-2995a90afa35

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

Version: 3

Effective Time: 20220415