FDA.reportPublic FDA data

Bio-G-Tuss

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:25

Label at a glance#

ProductBio-G-Tuss Pediatric Drops
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

helps lossen phlegm (mucus) and thin bronchial secretions to drain broncial tubes and make coughs more productive temporarily relieves nasal congestion due to hay fever or other respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold

Dosage and administration

 Age Dose   children 6 to under 12 years of age 2 mL every 6-8 hours   chidren 2 to under 6 years of age 1 mL every 6-8 hours   children under 2 years of age consult a doctor 

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • helps lossen phlegm (mucus) and thin bronchial secretions to drain broncial tubes and make coughs more productive
  • temporarily relieves nasal congestion due to hay fever or other respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

  • If nervousness dizziness, or sleeplessness ocurs, discontinue use and consult a doctor
  • If symptoms do not improve wihtin 7 days or are accompanied by fever, consult a doctor.

Do not use this product

  • for persistant or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.

Stop use and ask a doctor

  • A persistent cough may be a sign of a serious condition
  • if cough persists for more than onweek, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

 AgeDose 
 children 6 to under 12 years of age2 mL every 6-8 hours 
 chidren 2 to under 6 years of age1 mL every 6-8 hours 
 children under 2 years of ageconsult a doctor 

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions or Comments

OTC - QUESTIONS SECTION

1-305-403-3788

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioGTussPedDropsBioGTussPedDrops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1487369dextromethorphan HBr 7.5 MG / guaiFENesin 88 MG / phenylephrine HCl 2.5 MG in 1 mL Oral SolutionPSN4
1487369dextromethorphan hydrobromide 7.5 MG/ML / guaifenesin 88 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral SolutionSCD4
1487369dextromethorphan HBr 7.5 MG / guaifenesin 88 MG / phenylephrine HCl 2.5 MG per 1 ML Oral SolutionSY4

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
45737-240-022020-12-23C16284748780-19d75b9d1-1d22-f424-e053-dadaa90a57ceAGC-BioGTuss Ped Dr 240
45737-240-022020-01-31C16284748780-19d75b9d1-1d22-f424-e053-dadaa90a57ceAGC-BioGTuss Ped Dr 240

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-240-02Bio-G-TussPediatric Drops60 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-240BIO-G-TUSS PEDIATRIC DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ADVANCED GENERIC CORPORATION]4Legacy NDC, 1 package rows20241222_42045759-eaf2-4ffb-8a68-043f661acf8a.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-24045737-240-02

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
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM

Source Document#

Source XML · Source PDF

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
29bc1f35-6645-4435-e063-6394a90a520b42045759-eaf2-4ffb-8a68-043f661acf8a2024-12-20WarningsExact identifier
spl id: 29bc1f35-6645-4435-e063-6394a90a520b
spl set id: 42045759-eaf2-4ffb-8a68-043f661acf8a

Reported adverse events (FAERS/openFDA)#

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