FDA.reportPublic FDA data

GUAIASORB

Manufacturer
Geri-Care Pharmaceuticals, Corp
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:21:46

Label at a glance#

ProductGUAIASORB DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

per 10 mL = 2 teaspoonfuls

Dextromethorphan HBr - 20 mg

Guaifenesin - 200 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

WARNINGS SECTION

Warnings

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• if you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition.

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 exceed recommended dose
  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
Adults and children 12 years and over 10 mL (2 teaspoonfuls)
Children under 12 years Do not use

Other information

SPL UNCLASSIFIED SECTION

  • each 10 mL contains: sodium 20 mg
  • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from freezing
  • protect from light

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Geri Care®

GUAIASORB DM

SUGAR FREE ♦ DYE FREE ♦ ALCOHOL FREE

COUGH SUPPRESSANT

EXPECTORANT

For ages 12 years and over

Dist. By: Geri-Care Pharmaceuticals Corp.

1295 Towbin Avenue Lakewood, NJ 08701

Code# L-014

REV.: 05/24

PDP GUDMPDP GUDM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130357896739041GTIN-13: 0357896739041
EAN-13: 0357896739041
GTIN-12: 357896739041
UPC-A: 357896739041
GTIN storage (14 digits): 00357896739041		PDL 5789673904 GuaiasorbDM.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-739-04GUAIASORBDM118 mL in 1 BOTTLELIQUID1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-739-04ML - Milliliter57896-7398f83a444-d52a-4cd3-813a-bc7348eddd1412023-12-05

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
57896-73957896-739-04

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

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
GUAIASORB DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp09866b9c-aa32-45eb-e063-6394a90a49032025-12-11WarningsExact identifier
ndc (package): 57896-739-04
ndc (product): 57896-739
ndc11 (package): 57896073904
spl id: 45b05e0d-543d-f868-e063-6294a90a1283
spl set id: 09866b9c-aa32-45eb-e063-6394a90a4903

Reported adverse events (FAERS/openFDA)#

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