Robafen™ Syrup

Manufacturer: REMEDYREPACK INC.
Effective date: 2017-10-05
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:52:38

Label at a glance#

ProductROBAFEN COUGH FORMULA

Active ingredientGUAIFENESIN

Label structure11 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

each TSP (5 mL) contains: sodium 3 mg store at 20°-25°C (68°-77°F). Do not refrigerate.

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 2 TSP (10 mL) )

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin USP 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
a cough occurs with too much phlegm (mucus)

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

each TSP (5 mL) contains: sodium 3 mg
store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

SPL UNCLASSIFIED SECTION

Distributed by
MAJOR ^® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Remedy_Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	2
213155	Robafen 200 MG in 10 mL Oral Solution	PSN	2
213155	guaifenesin 20 MG/ML Oral Solution [Robafen]	SBD	2
310604	guaifenesin 20 MG/ML Oral Solution	SCD	2
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	2
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	2
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	2
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	2
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	2
213155	Robafen 100 MG per 5 mL Oral Solution	SY	2
213155	Robafen 200 MG per 10 mL Oral Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61786-963-45	2020-01-31	C162847	48780-1	9d75b9d1-1005-f424-e053-dadaa90a57ce	Robafen™ Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61786-963-45	ROBAFEN COUGH FORMULA	118 mL in 1 BOTTLE	SYRUP	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61786-963	ROBAFEN COUGH FORMULA (GUAIFENESIN) SYRUP [REMEDYREPACK INC.]	2	Legacy NDC, 1 package rows	20171006_f73e1db1-cd54-4e1e-a739-4be0d73ac4a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-0061-00	ML - Milliliter	0904-0061	ab74a419-4d6e-4e23-9a99-1f393c107cc2	1	2013-08-02
0904-0061-09	ML - Milliliter	0904-0061	70451862-9fed-4bf4-b236-a2f6f9fab1fd	1	2012-07-24
0904-0061-16	ML - Milliliter	0904-0061	5cef9570-dca3-44fb-9657-497b39927422	1	2013-08-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

ROBAFEN COUGH FORMULA
Guaifenesin
PROPYLENE GLYCOL
SODIUM BENZOATE
SACCHARIN SODIUM
ANHYDROUS CITRIC ACID
GLYCERIN
MENTHOL, UNSPECIFIED FORM
CORN SYRUP
WATER
CARAMEL
FD&C RED NO. 40

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61786-963	61786-963-45
0904-0061

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
CORN SYRUP	9G5L16BK6N	IACT
WATER	059QF0KO0R	IACT
CARAMEL	T9D99G2B1R	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5ad298e3-b90c-5332-e053-2a91aa0a4b4a			f73e1db1-cd54-4e1e-a739-4be0d73ac4a6	2017-10-05	Warnings	Exact identifier spl id: 5ad298e3-b90c-5332-e053-2a91aa0a4b4a spl set id: f73e1db1-cd54-4e1e-a739-4be0d73ac4a6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.