Guaifenesin and Dextromethorphan HBr

Manufacturer
Belleview Biosciences
Effective date
2024-07-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:36:58

Label at a glance#

ProductGuaifenesin and Dextromethorphan HBr
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions:
■ follow dosage below or use as directed by a physician
■ do not take more than 6 doses in any 24-hour period

WARNINGS SECTION

Warnings: Do not use if you are now taking a prescription monoamine oxidase inhibitor (MADI)
(certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease),or for 2
weeks after stopping the MADI drug.If you do not know if your
prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product.t
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 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.
■you are hypersensitive to any of the ingredients.

If pregnant or breastfeeding, 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Purpose:

Cough Suppressant and Expectorant

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 5 mL tsp)

Dextromethorphan HBr 10mg

Guaifenesin 100mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 84447-102-01

Guaifenesin/Dextromethorphan Oral Solution

Guaifenesin 100mg/5ml

Dextromethoprhan 10mg/5ml

PLEASE HANDLE CAREFULLY

Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

**Sugar, Alcohol, Gluten and Dye Free**

CAUTION:

FOR REPACKAGING ONLY

Store at controlled room temperature 15°-30°C (59°- 86°F)

84447-102 Bulk Label84447-102 Bulk Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-102-01Guaifenesin and Dextromethorphan HBr200000 mL in 1 DRUMLIQUID2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84447-102GUAIFENESIN AND DEXTROMETHORPHAN HBR (DEXTROMETHORPHAN HBR/GUAIFENESIN) LIQUID [BELLEVIEW BIOSCIENCES]11 package rows20241115_1db5ade4-8fba-110b-e063-6394a90add65.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84447-10284447-102-01

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1db57d93-e1d1-6860-e063-6294a90a6ca11db5ade4-8fba-110b-e063-6394a90add652024-07-20WarningsExact identifier
spl id: 1db57d93-e1d1-6860-e063-6294a90a6ca1
spl set id: 1db5ade4-8fba-110b-e063-6394a90add65

Reported adverse events (FAERS/openFDA)#

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