GUAIFENESIN AND DEXTROMETHORPHAN HBr

Manufacturer
Safecor Health, LLC
Effective date
2023-09-11
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
legacy-cache
Hydrated at
2026-08-01 21:26:16

Label at a glance#

ProductGUAIFENESIN AND DEXTROMETHORPHAN HBr
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each 5 mL = 1 teaspoonful)

Guaifenesin, USP 100 mg
Dextromethorphan HBr, USP 10 mg

OTC - PURPOSE SECTION

Purpose

Expectorant
Cough Suppressant

INDICATIONS & USAGE SECTION

Uses:
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
• helps loosen phlegm (mucus) and 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.

Do not use if you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • 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 persistent headache. 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 this and all drugs out of reach of children. In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. In case of eye contact, flush with water.

DOSAGE & ADMINISTRATION SECTION

Directions: Follow dosage below or use as directed by a doctor.

Do not take more than 6 doses in any 24-hour period.

AgeDose
Adults and children 12 years and over10 mL (2 teaspoonfuls) every 4 hours
Children 6 years to under 12 years5 mL (1 teaspoonful) every 4 hours
Children 2 years to under 6 years2.5 mL (1/2 teaspoonful) every 4 hours
Children under 2 yearsask a doctor

Other Information:

SPL UNCLASSIFIED SECTION

Each teaspoonful (5 mL) contains: sodium 2 mg. Store at room temperature 20°C-25°C (68°F - 77°F); excursions between 15°C-30°C (59°F
- 86°F) are allowed. Protect from freezing. Do not Refrigerate. Protect from light. For more info call 1-800-447-1006

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cherry Flavor, Citric Acid, FD&C Red # 40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.

SPL UNCLASSIFIED SECTION

NDC: 48433-221-05 GUAIFENESIN AND DEXTROMETHORPHAN HBr (100 mg / 10 mg per 5 mL) Unit Dose Cup

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204 
Guaifenesin and Dextromethorphan HBr Oral Solution (100 mg / 10 mg per 5 mL) Unit Dose Cup
Rev: 03/2021 PN5713
3 48433 22105 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 48433-221-05

Guaifenesin and

Dextromethorphan HBr

Oral Solution

100 mg/ 10 mg per 5 mL

Cherry Menthol Flavor

Alcohol Free

348433221051

Pkg By: Safecor Health, LLC

Columbus, OH 43204

Lid LabelLid Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-509-16ML - Milliliter54859-509c710a6f2-4893-4233-9200-88fd2ec455f012025-12-16

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48433-22148433-221-05, 48433-221-40
54859-509

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
ndc (product): 54859-509
12d4b49e-83c0-46ab-9588-cd306ad473cadea4f8c4-0d63-4edc-8e64-ccb8d1241a7d2023-09-11WarningsExact identifier
spl id: 12d4b49e-83c0-46ab-9588-cd306ad473ca
spl set id: dea4f8c4-0d63-4edc-8e64-ccb8d1241a7d

Reported adverse events (FAERS/openFDA)#

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