robafen dm

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2018-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:57:51

Label at a glance#

Productrobafen dm

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure9 sections

Indications and uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

• 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 mL every 4 hours children under 12 years do not use

Storage and handling

• Phenylketonurics: Contains Phenylalanine 30 mg per 10 mL • store at 20-25°C (68-77°F). Do not refrigerate.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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 mL

every 4 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

Phenylketonurics:Contains Phenylalanine 30 mg per 10 mL
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 N/E 16TH PLACE

MIAMI, FL 33179

NDC 17856-6759-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10mL

NDC 17856-6756-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	1
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	1
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	1
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	1
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-6759-1	2020-01-31	C162847	48780-1	9d75b9d1-1bd5-f424-e053-dadaa90a57ce	Major Pharmaceuticals Robafen ® DM Drug Facts
17856-6759-2	2020-01-31	C162847	48780-1	9d75b9d1-1bd5-f424-e053-dadaa90a57ce	Major Pharmaceuticals Robafen ® DM Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-6759-1	robafen dm	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	1
17856-6759-1	robafen dm	72 in 1 BOX, UNIT-DOSE	SOLUTION	72	1
17856-6759-2	robafen dm	72 in 1 BOX, UNIT-DOSE	SOLUTION	72	1
17856-6759-2	robafen dm	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-6759	ROBAFEN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 4 package rows	20181220_9157c28d-496b-41b1-9792-c811a2ba5ae7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6759-20	ML - Milliliter	0904-6759	40ad307b-05fb-4193-a647-d7015f29346a	1	2018-12-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

robafen dm
Dextromethorphan HBr, Guaifenesin
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
ASPARTAME
BENZOIC ACID
GLYCERIN
POLYETHYLENE GLYCOL
WATER
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-6759	17856-6759-1, 17856-6759-2
0904-6759

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
ASPARTAME	Z0H242BBR1	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	IACT

Source Document#

Source XML

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
49e0a727-3264-40d5-96c4-63080e389d90			9157c28d-496b-41b1-9792-c811a2ba5ae7	2018-12-19	Warnings	Exact identifier spl id: 49e0a727-3264-40d5-96c4-63080e389d90 spl set id: 9157c28d-496b-41b1-9792-c811a2ba5ae7

Reported adverse events (FAERS/openFDA)#

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