Guaifenesin and Dextromethorphan Hydrobromide Syrup

Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-04
Label type
HUMAN OTC DRUG LABEL
Version
101
Source
legacy-cache
Hydrated at
2026-08-01 21:05:56

Label at a glance#

ProductGuaifenesin and Dextromethorphan Hydrobromide
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure14 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age adults and children 12 years and over 2 teaspoonfuls (TSP) every 4 hours children under 12 years DO NOT USE

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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

your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days or occurs with fever, rash, or
    headaches that lasts. This could be a sign of a serious condition
  • hypersensitive to any ingredients

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age
adults and children 12 years and over2 teaspoonfuls (TSP) every 4 hours
children under 12 yearsDO NOT USE

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20°-25°C (68°-77°F)

Questions

OTC - QUESTIONS SECTION

1-877-250-3427

HOW SUPPLIED

How Supplied Section

Guaifenesin and Dextromethorphan Hydrobromide Syrup

  • NDC 72162-1670-2: 237 mL in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL

Label
Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1670-2ML - Milliliter72162-1670256e99f5-c7f8-436f-986c-f49e47b6bbc612023-12-05

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72162-167072162-1670-2
58657-505

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Dextromethorphan HydrobromideGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEMethod Pharmaceuticals389230e5-775e-5b0d-e054-00144ff88e882025-10-21WarningsExact identifier
ndc (product): 58657-505
5c55e201-67d7-41ad-a3f1-c2ec0722f1552ef1240f-5789-4002-a121-f97a7aec751b2024-09-27WarningsExact identifier
spl set id: 2ef1240f-5789-4002-a121-f97a7aec751b

Reported adverse events (FAERS/openFDA)#

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