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
temporarily relieves cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Cough suppressant
Expectorant
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 health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years and over | 2 teaspoonfuls (TSP) every 4 hours |
| children under 12 years | DO NOT USE |
Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF
1-877-250-3427
Method Pharmaceuticals
NDC 58657-505-08
Guaifenesin and Dextromethorphan Hydrobromide Syrup
100 mg/10 mg/5 mL
Expectorant
Cough Suppressant
Grap Flavor
Non Drowsy • Alcohol Free
FOR AGES 12 AND UP
8 fl. oz. (237 mL)
Manufactured For:
Method Pharmaceuticals, LLC
Fort Worth, TX 76118 Rev. 06/2016
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 9 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 9 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 9 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 9 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 9 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58657-505-08 | 2020-02-11 | C162847 | 48780-1 | 9d75b9d0-d8b8-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan Hydrobromide Syrup |
| 58657-505-08 | 2020-02-11 | C162847 | 48780-1 | 9d75b9d0-d8b8-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan Hydrobromide Syrup |
| 58657-505-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d8b8-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan Hydrobromide Syrup |
| 58657-505-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d8b8-f424-e053-dadaa90a57ce | Guaifenesin and Dextromethorphan Hydrobromide Syrup |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-505-08 | Guaifenesin and Dextromethorphan Hydrobromide | 237 mL in 1 BOTTLE, PLASTIC | SYRUP | 237 | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58657-505 | 58657-505-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| SORBITOL | 506T60A25R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 8 | 2024-11-29 | full-release | 2026-06-01 00:39:51 |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 389230e5-775e-5b0d-e054-00144ff88e88 | 2025-10-21 | Warnings | 58657-505-08 58657-505 58657050508 41b5005a-2f6d-775b-e063-6294a90aa66e 389230e5-775e-5b0d-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.