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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 9 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 9 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 9 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 9 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 9 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45737-209-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-f8ef-f424-e053-dadaa90a57ce | AGC-Biocotron 209 |
| 45737-209-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f8ef-f424-e053-dadaa90a57ce | AGC-Biocotron 209 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45737-209-16 | Biocotron | 473 mL in 1 BOTTLE | LIQUID | 473 | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45737-209-16 | ML - Milliliter | 45737-209 | 33c913b0-ded1-46f8-a9d8-a7f4d68aaaa9 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 1 |
Products#
Every source-derived product name is available through these pages.
- Biocotron
- Dextromethorphan, Guaifenesin
- CITRIC ACID MONOHYDRATE
- WATER
- METHYLPARABEN
- PROPYLENE GLYCOL
- SODIUM CITRATE
- PROPYLPARABEN
- SUCRALOSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45737-209 | 45737-209-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| WATER | 059QF0KO0R | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2a33054e-eac2-722f-e063-6394a90a4275 | 91d90a98-38ce-46f0-a31a-ac00937474aa | 2024-12-26 | Warnings | 2a33054e-eac2-722f-e063-6394a90a4275 91d90a98-38ce-46f0-a31a-ac00937474aa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
