FDA.reportPublic FDA data

Bisolvine

Manufacturer
MENPER DISTRIBUTORS INC. | RNV, LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:08:19

Label at a glance#

ProductBisolvine Children
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections

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.

Dosage and administration

Age  Dose  Children 6 to under 12 years of age  1 teaspoonful (15 mL) every 4 hours  Children 2 to under 6 years of age  1/2 teaspoonful (7.5 mL) every 4 hours  Children under 2 years of age  Consult your doctor

Label contents#

Full prescribing information#

Active Ingredients (in each 15 mL)

OTC - ACTIVE INGREDIENT SECTION

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

Dextromethorphan.............................................. Cough Suppressant

Purpose

OTC - PURPOSE SECTION

Expectorant

Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

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: 

WARNINGS SECTION

Do not exceed recommended dosage.

A persistent 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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • give this product for persistent or chronic cough, such as occurs with asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Age

 Dose
 Children 6 to under 12 years of age 1 teaspoonful (15 mL) every 4 hours
 Children 2 to under 6 years of age 1/2 teaspoonful (7.5 mL) every 4 hours
 Children under 2 years of age Consult your doctor

OTHER SAFETY INFORMATION

store this product between 15° to 30° C (59°-86° F)

INACTIVE INGREDIENT SECTION

artificial strawberryt-banana flavor, citric acid, fd&c red #40, glycerin, methylparaben, propylene glycol, propylparaben, puridied water, sucrose.

Questions?

OTC - QUESTIONS SECTION

1-800-560-5223 M-F 9 AM to 4 PM Eastern.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisolvine ChildrenBisolvine Children

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN4
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD4
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY4
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSY4

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
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
53145-322-042023-07-28C16284748780-1d6a99b39-6d88-a426-e053-dadaa90af4c2Bisolvine Children
53145-322-042022-02-18C16284748780-1d6a99b39-6d88-a426-e053-dadaa90af4c2Bisolvine Children
53145-322-042022-01-28C16284748780-1d6a99b39-6d88-a426-e053-dadaa90af4c2Bisolvine Children

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-322-04BisolvineChildren1 in 1 CARTONLIQUID14
53145-322-04BisolvineChildren120 mL in 1 BOTTLELIQUID1204

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-32253145-322-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
ndc (package): 53145-322-04
ndc (product): 53145-322
ndc11 (package): 53145032204
spl id: 3a8ae821-335c-8faf-e063-6394a90ab4bd
spl set id: 896a5443-e3d2-4af7-9e27-f1c1899ce038

Reported adverse events (FAERS/openFDA)#

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