Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc.

Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2026-09-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-25 02:01:57

Label at a glance#

ProductDextromethorphan HBr. and Guaifenesin
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 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

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

10 mg-100 mg/5 mL -

Active ingredient per 5 mL (1 unit dose) 

Dextromethorphan HBr. 10 mg

Guaifenesin 100 mg

20 mg-200 mg/10 mL -

Active ingredient per 10 mL (1 unit dose)    

Dextromethorphan HBr. 20 mg

Guaifenesin 200 mg

Purpose

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

OTC - DO NOT USE SECTION

Do not use 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

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 persistant headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

•   do not take more than 6 doses in any 24 hour period

20 mg-200 mg/10 mL

agedose
Children under 12 years of age

Do not use

Adults and children over 12 years of age

10 mL (1 unit dose) every 4 hours

10 mg-100 mg/5 mL

agedose
Children under 6 years of ageDo not use
Children 6 to under 12 years of age5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age10 mL (2 unit dose) every 4 hours

OTHER SAFETY INFORMATION

Other Information
•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   do not use if lid is torn or broken

INACTIVE INGREDIENT SECTION

Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

HOW SUPPLIED SECTION

NDC Information -

Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

NDC 57237-312-05  unit dose cup 5mL
NDC 57237-312-51 (100 x 5 mL) unit-dose cups


Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms:

NDC 57237-313-01 unit dose cup 10mL
NDC 57237-313-18 (80 x 10 mL) unit-dose cups

OTC - QUESTIONS SECTION

Questions or comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 04/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 mg-100 mg/5 mL

Lid Label       NDC 57237-312-05

Guai-Dextro-lid-label-5mlGuai-Dextro-lid-label-5ml

Case Label    NDC 57237-312-51

Guai-Dextro-case-label-5mlGuai-Dextro-case-label-5ml

20 mg-200 mg/10 mL

Lid Label       NDC  57237-313-01

Guai-Dextro-lid-label-10mlGuai-Dextro-lid-label-10ml

Case Label    NDC  57237-313-18

Guai-Dextro-case-label-10mlGuai-Dextro-case-label-10ml

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1285723731205Guai-Dextro-lid-label-5ml.jpg
Data codeCode 1285723731301Guai-Dextro-lid-label-10ml.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-312-05ML - Milliliter57237-312b4445953-07cc-4aef-bec3-b0d9427f679812023-07-06
57237-312-51ML - Milliliter57237-312474f4a31-90f7-44ca-8151-f945ba6b798712023-07-06
57237-313-01ML - Milliliter57237-313b4b7f776-ef79-4ae7-91fd-645b4e7d702c12023-07-06
57237-313-18ML - Milliliter57237-3131a032e32-c5d7-44b4-8e28-95a98c950ff812023-07-06

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57237-31257237-312-05, 57237-312-51
57237-31357237-313-01, 57237-313-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-07-01full-release2026-06-01 01:06:42

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
914d13bb-fbd6-420f-ad2c-1df3828d18c3e463e60f-d0db-4ee7-9713-ddf25aa38a432025-07-01WarningsExact identifier
spl set id: e463e60f-d0db-4ee7-9713-ddf25aa38a43

Reported adverse events (FAERS/openFDA)#

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