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#
Contacts and useful links#
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.
| Age | Dose |
| Adults and children 12 years and over | 10 mL (2 teaspoonfuls) every 4 hours |
| Children 6 years to under 12 years | 5 mL (1 teaspoonful) every 4 hours |
| Children 2 years to under 6 years | 2.5 mL (1/2 teaspoonful) every 4 hours |
| Children under 2 years | ask a doctor |
Other Information:
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
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-509-16 | ML - Milliliter | 54859-509 | c710a6f2-4893-4233-9200-88fd2ec455f0 | 1 | 2025-12-16 |
Products#
Every source-derived product name is available through these pages.
- GUAIFENESIN AND DEXTROMETHORPHAN HBr
- guaifenesin and dextromethorphan hydrobromide
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- MENTHOL
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48433-221 | 48433-221-05, 48433-221-40 |
| 54859-509 |
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 |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| Tusnel Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | af71cdbc-33d6-4303-b494-d7321721d3be | 2025-12-31 | Warnings | 54859-509 |
| 12d4b49e-83c0-46ab-9588-cd306ad473ca | dea4f8c4-0d63-4edc-8e64-ccb8d1241a7d | 2023-09-11 | Warnings | 12d4b49e-83c0-46ab-9588-cd306ad473ca dea4f8c4-0d63-4edc-8e64-ccb8d1241a7d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
