Label at a glance#

ProductGuaifenesin and Dextromethorphan

Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Dosage and administration

Follow dosage below or use as directed by a physician.  do not take more than 6 doses in any 24-hour period.  single use cup. Dose only with cup provided.  each cup delivers 5 mL  mL = Milliliter Age (yr) Dose (mL) adults and children 12 years and over 10 mL every 4 hours children 6 years to under 12 years 5 mL every 4 hours children under 6 years of age ask a doctor

Storage and handling

 Each 5 mL contains: sodium 4 mg.  Store at 20° to 25°C (68° to 77°F). Protect from light.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-845-8210

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL cup) Purpose

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 100 mg .............................................................................................................................. Expectorant
Dextromethorphan hydrobromide 10 mg ............................................................................................ Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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

Follow dosage below or use as directed by a physician.
 do not take more than 6 doses in any 24-hour period.
 single use cup. Dose only with cup provided.
 each cup delivers 5 mL
 mL = Milliliter

Age (yr)	Dose (mL)
adults and children 12 years and over	10 mL every 4 hours
children 6 years to under 12 years	5 mL every 4 hours
children under 6 years of age	ask a doctor

Other information

STORAGE AND HANDLING SECTION

 Each 5 mL contains: sodium 4 mg.
 Store at 20° to 25°C (68° to 77°F). Protect from light.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Red No. 40, flavor, glycerin, menthol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

Call1-800-845-8210

How Supplied

HOW SUPPLIED SECTION

Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form:
NDC 0904-7512-41: 5 mL unit dose cup, in a tray of ten cups.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

R10/24

Distributed by:

MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL
NDC 0904-7512-41

GUAIFENESIN and DEXTROMETHORPHAN
Syrup

100 mg/10 mg per 5 mL

See Insert for Drug Facts
For Institutional Use Only

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	4
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	4
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	4
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	4
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	4

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7512-41	Guaifenesin and Dextromethorphan	5 mL in 1 CUP, UNIT-DOSE	SYRUP	5	4
0904-7512-70	Guaifenesin and Dextromethorphan	10 in 1 CASE	SYRUP	10	4
0904-7512-70	Guaifenesin and Dextromethorphan	10 in 1 TRAY	SYRUP	10	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7512	GUAIFENESIN AND DEXTROMETHORPHAN SYRUP [MAJOR PHARMACEUTICALS]	4	Current NDC, 3 package rows	20250211_97b137c9-0bec-409a-91f7-e298c296578b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7512-41	ML - Milliliter	0904-7512	9cdd17b4-83f5-4ebf-b719-12a23d2030e0	1	2025-03-04
0904-7512-70	ML - Milliliter	0904-7512	367db5fb-c75b-41e4-8c2b-f37c3d5ae9cf	1	2025-03-04

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Guaifenesin and Dextromethorphan
GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
MENTHOL
GLYCERIN
WATER
SACCHARIN SODIUM
SUCROSE
SODIUM BENZOATE
SODIUM CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-7512	0904-7512-41, 0904-7512-70

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
GUAIFENESIN	495W7451VQ	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MENTHOL	L7T10EIP3A	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SUCROSE	C151H8M554	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	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
Guaifenesin and Dextromethorphan	GUAIFENESIN AND DEXTROMETHORPHAN	Major Pharmaceuticals	97b137c9-0bec-409a-91f7-e298c296578b	2025-01-29	Warnings	Exact identifier ndc (package): 0904-7512-41 ndc (package): 0904-7512-70 ndc (product): 0904-7512 ndc11 (package): 00904751270 ndc11 (package): 00904751241 spl id: 7a9d1e3e-d1ad-4b40-9f77-6df15fecacc2 spl set id: 97b137c9-0bec-409a-91f7-e298c296578b

Reported adverse events (FAERS/openFDA)#

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

Guaifenesin Syrup and Dextromethorphan Syrup Expectorant/Cough Suppressant