Indications and uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Bisolvine
- Manufacturer
- MENPER DISTRIBUTORS INC.
- Effective date
- 2022-02-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:21
Label at a glance#
ProductBisolvine Adult
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections
Dosage and administration
Do not exceed 6 doses in 24 hours Age Dose Adults and Children 12 years of age and over 2 teaspoonfuls (10 ml) every 4 hours Children under 12 years of age Do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients (in each 10 mL) Purpose
Dextromethorphan 20 mg.............................................. Cough Suppressant
Guaifenesin 200 mg ...................................................... Expectorant
Purpose
Cough Suppressant
Expectorant
Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Warnings
Do not exceed recommended dosage.
A persistent or chronic cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do not use:
- this product for persistent or chronic cough, such as occurs with smoking, asthma, chronic brochitis or emphysema or if cough is accompanied by excessive phlegm (mucus), 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed 6 doses in 24 hours
| Age | Dose |
| Adults and Children 12 years of age and over | 2 teaspoonfuls (10 ml) every 4 hours |
| Children under 12 years of age | Do not use |
Inactive ingredients
artificial strawberry-banana flavor, citric acid, fd&c red #40, glycerin, methyl paraben, propylene glycol, propylparaben, sucrose, water
Questions?
Questions? call 1-800-560-5523 M-F 9 AM to 4 PM Eastern.
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 | 2 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 2 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 2 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 2 |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-325-04 | 2023-07-28 | C162847 | 48780-1 | d6a99b39-c73f-a426-e053-dadaa90af4c2 | e67a240a-7dbf-4bac-92ec-85f1823677f3 |
| 53145-325-04 | 2022-02-18 | C162847 | 48780-1 | d6a99b39-c73f-a426-e053-dadaa90af4c2 | e67a240a-7dbf-4bac-92ec-85f1823677f3 |
| 53145-325-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-c73f-a426-e053-dadaa90af4c2 | e67a240a-7dbf-4bac-92ec-85f1823677f3 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-325-04 | BisolvineAdult | 120 mL in 1 BOTTLE, PLASTIC | LIQUID | 120 | 2 | |
| 53145-325-04 | BisolvineAdult | 1 in 1 CARTON | LIQUID | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Bisolvine Adult
- Guaifenesin, Dextromethorphan
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- METHYLPARABEN
- GLYCERIN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53145-325 | 53145-325-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCROSE | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| 2b939fcd-c0ac-474e-9b85-e639718e3cb2 | e67a240a-7dbf-4bac-92ec-85f1823677f3 | 2022-02-18 | Warnings | 2b939fcd-c0ac-474e-9b85-e639718e3cb2 e67a240a-7dbf-4bac-92ec-85f1823677f3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.