FDA.reportPublic FDA data

Brontuss

Manufacturer
Portal Inc.
Effective date
2010-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:39

Label at a glance#

ProductBrontuss SF
Active ingredientDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Label structure8 sections

Indications and uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation helps losen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and Children 12 years of age and over: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 doses in a 24 hour period. Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 6 doses in a 24 hour period. Children under 6 years of age: Consult a doctor

Storage and handling

Each 5mL teaspoonful contains 5 mg sodium. Store at 59 o -86 o F(15 o -30 o C)

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION


Active ingredients                                              Purpose
(in each 5 mL teaspoonful)
Dextromethorphan Hydrobromide 15 mg..................Antitussive
Guaifenesin 300 mg...............................................Expectorant
Phenylephrine Hydrochloride 10 mg.........................Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps losen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

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

  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Adults and Children 12 years of
age and over:
1 teaspoonful (5 mL) every 4 hours, not to
exceed 6 doses in a 24 hour period.
Children 6 to under 12 years of
age:
1/2 teaspoonful (2.5 mL) every 4 hours, not to
exceed 6 doses in a 24 hour period.
Children under 6 years of age:
Consult a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Each 5mL teaspoonful contains 5 mg sodium.
  • Store at 59o-86oF(15o-30oC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions? Comments?

OTC - QUESTIONS SECTION

Call your doctor for medical advise about side effects.  Serious side effects associated with this product
may be reported to this number.
Call (787) 832-6645
Operation Hours:  Monday-Friday, 8 A.M. to 4 P.M.
Atlantic Standard Time (AST)

Manufactured for: Portal Pharmaceuticals, Mayaguez, PR  00680
portalpharmaceutical@gmail.com                                Rev. 02/10

Product Packaging:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging below represents the labeling currently used:

Principal display panel and side panel for 30 mL label:

NDC 49963-813-01

Brontuss SF Liquid
Antitussive/Expectorant/Nasal Decongestant

Each teaspoonful (5 mL) for
oral administration contains:
Dextromethorphan HBr.........................15 mg
Guaifenesin.......................................300 mg
Phenylephrine HCl...............................10 mg

Dye Free/Sugar Free/Alcohol Free

1 oz. (30 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child-resistant cap.

Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680                     Rev. 02/10




Principal display panel and side panel for 118 mL label:

NDC 49963-813-04

Brontuss SF Liquid

Antitussive/Expectorant/Nasal Decongestant

Each teaspoonful (5 mL) for
oral administration contains:
Dextromethorphan HBr..........................15 mg
Guaifenesin........................................300 mg
Phenylephrine HCl................................10 mg

Dye Free/Sugar Free/Alcohol Free

4 oz. (118 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Supplied in a tight, light-resistant container with a child resistant cap.

Manufactured for:
PORTAL Pharmaceutical
Mayaguez, PR  00680

Rev. 02/10


Brontuss SF Packaging
Brontuss SF Packaging


Brontuss SF Packaging
Brontuss SF Packaging
















DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251031dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN1
1251031dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD1
1251031dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49963-813-012019-10-21C16284748780-1956f9ecf-c6ea-621f-e053-dbdaa90a74adBrontuss SF Liquid
49963-813-042019-10-21C16284748780-1956f9ecf-c6ea-621f-e053-dbdaa90a74adBrontuss SF Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49963-813-01Brontuss SF30 mL in 1 BOTTLELIQUID301
49963-813-04Brontuss SF118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49963-813BRONTUSS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL INC.]1Legacy NDC, 2 package rows20100601_4f816062-aaf6-4526-8269-2671c88cab1e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49963-813-04ML - Milliliter49963-813a77db37f-6f63-48eb-8aa4-357636980d8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
DextromethorphanACTIVE MOIETY7355X3ROTS1
GuaifenesinACTIVE MOIETY495W7451VQ1
PhenylephrineACTIVE MOIETY1WS297W6MV1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49963-81349963-813-04, 49963-813-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dextromethorphan Hydrobromide9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB

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
e1f6b972-4786-4c51-aaf8-181d6da0f5e84f816062-aaf6-4526-8269-2671c88cab1e2010-05-12WarningsExact identifier
spl id: e1f6b972-4786-4c51-aaf8-181d6da0f5e8
spl set id: 4f816062-aaf6-4526-8269-2671c88cab1e

Reported adverse events (FAERS/openFDA)#

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