Biocotron

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:49:10

Label at a glance#

ProductBiocotron
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: (in each 5 mL tsp.)              Purpose

Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

Guaifenesin 100 mg .............................................. Expectorant

OTC - PURPOSE SECTION

Purpose

Cough suppressant

Expectorant

WARNINGS SECTION

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.

When using this product,

do not exceed recommended dosage 


Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 you are taking a prescription drug that contains an MAOI;ask your doctor or pharmacist before taking this product.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician.

 Age Dose
 adults and children 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
 children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours 
 children under 6 years  ask a doctor 

INDICATIONS & USAGE SECTION

Uses

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

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, cherry flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

OTC - QUESTIONS SECTION

Questions or comments?1-305-403-3788
Manufactured For:Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biocotron LabelBiocotron Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN9
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD9
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY9
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY9
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY9

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-209-162020-12-23C16284748780-19d75b9d0-f8ef-f424-e053-dadaa90a57ceAGC-Biocotron 209
45737-209-162020-01-31C16284748780-19d75b9d0-f8ef-f424-e053-dadaa90a57ceAGC-Biocotron 209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-209-16Biocotron473 mL in 1 BOTTLELIQUID4739

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-209BIOCOTRON (DEXTROMETHORPHAN, GUAIFENESIN) LIQUID [ADVANCED GENERIC CORPORATION]9Legacy NDC, 1 package rows20241228_91d90a98-38ce-46f0-a31a-ac00937474aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-209-16ML - Milliliter45737-20933c913b0-ded1-46f8-a9d8-a7f4d68aaaa912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
DextromethorphanACTIVE MOIETY7355X3ROTS1
GuaifenesinACTIVE MOIETY495W7451VQ1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-20945737-209-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
2a33054e-eac2-722f-e063-6394a90a427591d90a98-38ce-46f0-a31a-ac00937474aa2024-12-26WarningsExact identifier
spl id: 2a33054e-eac2-722f-e063-6394a90a4275
spl set id: 91d90a98-38ce-46f0-a31a-ac00937474aa

Reported adverse events (FAERS/openFDA)#

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