• Temporarily controls cough due to minor throat and bronchial irritation as may occur with a cold • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive .
Children 6 to under 12 years of age • 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor • Children under 6, consult a doctor
www.kramernovis.comDextromethorphan HBr, 5 mg
Guaifenesin, 50 mg
Cough Suppressant
Expectorant
• Temporarily controls cough due to minor throat and bronchial irritation as may occur with a cold
• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.
Do not use:
in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if your child has
When using this product do not exceed the recommended dosage.
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Children 6 to under 12 years of age
• 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor
• Children under 6, consult a doctor
Citric acid, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.
• Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
• Store at controlled room temperature 15°-30°C (59°-86°F).
• Avoid excessive heat and humidity.
COUGH SUPPRESSANT
EXPECTORANT
No sugar, dye, alcohol, aspartame or sorbitol
DECONGESTANT FREE
Manufacture in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1439992 | dextromethorphan HBr 5 MG / guaiFENesin 50 MG in 1 mL Oral Solution | PSN | 5 |
| 1439992 | dextromethorphan hydrobromide 5 MG/ML / guaifenesin 50 MG/ML Oral Solution | SCD | 5 |
| 1439992 | dextromethorphan hydrobromide 5 MG/ML / GG 50 MG/ML Oral Solution | SY | 5 |
| 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 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 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 |
|---|---|---|---|---|---|
| 52083-058-01 | 2025-11-18 | C162847 | 48780-1 | 2cef2736-5f9c-d83d-e063-dadaa90ab31f | Supress DM |
| 52083-058-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5f9c-d83d-e063-dadaa90ab31f | Supress DM |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-058-01 | Supress DM | 30 mL in 1 BOTTLE | SYRUP | 30 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-058-01 | ML - Milliliter | 52083-058 | 9db1418f-5f10-40ad-9fa8-1f0b9c5e8a85 | 1 | 2013-12-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52083-058 | 52083-058-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg |
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 |
|---|---|---|---|---|---|---|
| Supress DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | KRAMER NOVIS | 7da0611e-729c-4cf8-88f3-f8877b9f5cfa | 2025-11-14 | Warnings | 52083-058-01 52083-058 52083005801 974dbf24-7689-4e94-a535-d5b59c097406 7da0611e-729c-4cf8-88f3-f8877b9f5cfa |
Adverse event summaries are temporarily unavailable. Other product information remains available.