BioGtuss
- Manufacturer
- Advanced Generic Corporation
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:47:02
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
Guaifenesin 300 mg .............................................. Expectorant
Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant
Phenylephrine HCl 10 mg.................................. Decongestant
OTC - PURPOSE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
- temporarily relieves nasal congestion and cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants.
WARNINGS SECTION
Warnings
- Do not exceed recommended dosage
- A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
- May cause or aggravate constipation
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
OTC - DO NOT USE SECTION
Do not Use
- For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor
- If you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by a doctor. 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.
If you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
DirectionsDo not exceed 6 doses in 24 hours.
adults and children 12 years of age and over take 1 teaspoonful (5 mL) every 4 hours
children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 4 hours
children under 6 years of age ask a doctor
INDICATIONS & USAGE SECTION
Other information store at room temperature 15°- 30°C (59° - 86°F).
Tamper Evident Feature:
Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.
Warning:Phenylketonuric. Contains 17 mg of Phenylalanine per 5 mL (one teaspoonful dose).
INACTIVE INGREDIENT SECTION
Inactive Ingredients aspartame, citric acid, D and C Red No 33, FD and C Blue No 1, glycerine, hydroxymethyl cellulose, methylparaben, natural and artificial flavors, propylene glycol, propylparaben, purified water, sodium citrate
OTC - QUESTIONS SECTION
Questions or comments?1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, Fl 33166
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1251031 | dextromethorphan HBr 15 MG / guaiFENesin 300 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 8 |
| 1251031 | dextromethorphan hydrobromide 3 MG/ML / guaifenesin 60 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 8 |
| 1251031 | dextromethorphan HBr 15 MG / guaifenesin 300 MG / phenylephrine HCl 10 MG per 5 ML Oral Solution | SY | 8 |
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 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45737-205-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-c39d-f424-e053-dadaa90a57ce | AGC-BioGTuss 205 |
| 45737-205-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c39d-f424-e053-dadaa90a57ce | AGC-BioGTuss 205 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45737-205-16 | BioGtuss | 473 mL in 1 BOTTLE | LIQUID | 473 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45737-205-16 | ML - Milliliter | 45737-205 | 2f7a12d1-b2dd-4e1a-994c-c9aa229fe6f4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 4 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 4 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 4 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 4 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 4 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 4 | |
| Aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | 4 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 4 | |
| D&C Red No. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 4 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 4 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| Hydroxymethyl Cellulose | INACTIVE INGREDIENT | 273FM27VK1 | 4 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 4 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- BioGtuss
- Dextromethorphan, Guaifenesin, Phenylephrine
- GLYCERIN
- WATER
- METHYLPARABEN
- PROPYLPARABEN
- PROPYLENE GLYCOL
- SODIUM CITRATE
- CITRIC ACID MONOHYDRATE
- ASPARTAME
- D&C RED NO. 33
- FD&C BLUE NO. 1
- HYDROXYMETHYL CELLULOSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45737-205 | 45737-205-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYDROXYMETHYL CELLULOSE | 273FM27VK1 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Aspartame | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INHALANT / RESPIRATORY (INHALATION) | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 608 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| Aspartame | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / RESPIRATORY (INHALATION) | 0.13 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| Aspartame | ASPARTAME | Z0H242BBR1 | FILM, EXTENDED RELEASE / BUCCAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA |
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 |
|---|---|---|---|---|---|---|
| 29bc44b3-32be-9b2d-e063-6394a90a9d2e | 28c143f4-1575-44fe-871c-8e281322994e | 2024-12-20 | Warnings | 29bc44b3-32be-9b2d-e063-6394a90a9d2e 28c143f4-1575-44fe-871c-8e281322994e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
