Indications and uses
• temporarily relieves cough • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
Dextromethorphan HBr and Guaifenesin
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2020-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:44:23
Label at a glance#
ProductDextromethorphan HBr and Guaifenesin
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections
Dosage and administration
• take every 4 hours • do not exceed 6 doses in 24 hours Age Dose Adults & children 12 years & over 10 mL (2 teaspoonfuls) Children 6 years to under 12 years 5 mL (1 teaspoonful) Children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) Children under 2 years Ask a doctor How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Each 5 mL (1 teaspoonful) contains:
Dextromethorphan HBr ................................10 mg
Guaifenesin ................................................100 mg
Inactive ingredients
Acesulfame potassium, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.
Purpose
Cough Suppressant
Expectorant
Uses
- temporarily relieves cough
- helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
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 two 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
- a cough that occur with too much phlegm (mucus)
- a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- a cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
- These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Professional note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5- hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Directions
- take every 4 hours
- do not exceed 6 doses in 24 hours
Age | Dose |
Adults & children 12 years & over | 10 mL (2 teaspoonfuls) |
Children 6 years to under 12 years | 5 mL (1 teaspoonful) |
Children 2 years to under 6 years | 2.5 mL (1/2 teaspoonful) |
Children under 2 years | Ask a doctor |
How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
Storage: Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.
QUESTIONS OR COMMENTS?
Call 1-800-262-9010.
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev.062:01 4/13
MG #29851
HOW SUPPLIED
Product: 50090-3251
NDC: 50090-3251-0 10 mL in a CUP, UNIT-DOSE / 10 in a TRAY
Dextromethorphan HBr and Guaifenesin
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50383-062-05 | ML - Milliliter | 50383-062 | 3b76b61d-6899-435b-8d7b-f22839e108c3 | 1 | 2013-03-03 |
| 50383-062-06 | ML - Milliliter | 50383-062 | 33711fd0-1dcd-49bd-96e0-872094c2444e | 1 | 2013-04-01 |
| 50383-062-07 | ML - Milliliter | 50383-062 | c141208d-32c2-42be-8255-dd4390799d58 | 1 | 2013-04-01 |
| 50383-062-10 | ML - Milliliter | 50383-062 | 60cbe226-4e0b-4d6e-886c-ca1d2e0e621b | 1 | 2013-03-03 |
| 50383-062-11 | ML - Milliliter | 50383-062 | 374a31ec-bcfd-4172-9491-42fd98a7fbd1 | 1 | 2013-04-01 |
| 50383-062-12 | ML - Milliliter | 50383-062 | a6540397-da10-4136-aaad-7a30c5d09a92 | 1 | 2013-04-01 |
Products#
Every source-derived product name is available through these pages.
- Dextromethorphan HBr and Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ACESULFAME POTASSIUM
- ASPARTAME
- HYPROMELLOSE 2910 (4000 MPA.S)
- MENTHOL, UNSPECIFIED FORM
- METHYLPARABEN
- POTASSIUM SORBATE
- WATER
- ANHYDROUS CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-3251 | 50090-3251-0 |
| 50383-062 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| HYPROMELLOSE 2910 (4000 MPA.S) | RN3152OP35 | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| WATER | 059QF0KO0R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | 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 |
|---|---|---|---|---|---|---|
| abe3938d-0831-4a39-96ac-ed0097cc5244 | 00f9ad4c-4f5b-4c85-a423-d7c5daaff97b | 2021-04-16 | Warnings | 00f9ad4c-4f5b-4c85-a423-d7c5daaff97b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.