Indications and uses
• temporarily relieves cough due to minor throat and bronchial irritation • helps loosen phlegm (mucus) • helps thin bronchial secretions to make coughs more productive
Chest Congestion Relief
- Manufacturer
- Major Pharmaceuticals
- Effective date
- 2024-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:48:49
Label at a glance#
ProductChest Congestion Relief DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure12 sections
Dosage and administration
Directions • take every 4 hours as needed, or as directed by a doctor • do not take more than 6 doses in 24 hours • do not exceed recommended dose Adults and children 12 years and over 2 teaspoonsfuls (10 mL) Children under 12 years do not use
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
Active ingredient (per 5mL teaspoonful)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Purpose
Cough suppressant
Expectorant
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Uses
• temporarily relieves cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus)
• helps thin bronchial secretions to make coughs more productive
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 Doctor
before use if you have
• a cough with too much phlegm (mucus)
• a 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 headache that lasts. These could be signs of a serious condition.
If Pregnancy or Breast Feeding
ask a health professional before use.
Directions
Directions
• take every 4 hours as needed, or as directed by a doctor
• do not take more than 6 doses in 24 hours
• do not exceed recommended dose
Adults and children 12 years and over | 2 teaspoonsfuls (10 mL) |
Children under 12 years | do not use |
Other Information
• each teaspoon (5 mL) contains: sodium 2mg
• store at room temperature 15°-30°C (59°-86°F)
• protect from freezing
• do not refrigerate
• protect from light
• Pharmacist-Preserve and dispense in a tight, light-resistant container with a child resistant cap as defined in the USP
• TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn broken or missing.
Inactive Ingredients
cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.
Questions
or comments? 1-800-645-2158
This product
is not manufactured or distributed by the owner of the registered trademark Robitussin® DM.
THIS IS A BULK CONTAINER NOT INTENDED FOR DISPENSING.
Distributed by:
RUGBY LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Packaged and Distributed by FOR INTITUTIONAL USE ONLY:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 USA
Refer to package label for Distributor's NDC Number
Rev. 08/20 | R-164 | Re-order No. 371050 |
Package/Label Principal Display Panel
MAJOR®
NDC 0904-7134-70
Guaifenesin
Dextromethorphan
Syrup
100 mg/10 mg per 5 mL
Delivers 5 mL
See insert
For Institutional Use Only
Alcohol Free
Cherry Flavor
MAJOR PHARMACEUTICALS
Indianapolis, IN 46268
Principal Display Panel
Product Insert
Guaifenesin
Dextromethorphan Syrup
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7134-70 | ML - Milliliter | 0904-7134 | b287799f-5646-4729-94ad-72b2f3454222 | 1 | 2022-03-09 |
Products#
Every source-derived product name is available through these pages.
- Chest Congestion Relief DM
- Dextromethorphan Hydrobromide, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- MENTHOL, UNSPECIFIED FORM
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE, UNSPECIFIED FORM
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-7134 | 0904-7134-70 |
| 0536-1313 |
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, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 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 |
|---|---|---|---|---|---|---|
| Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | RUGBY LABORATORIES | 60c9e493-f58c-45d6-bade-c95297512403 | 2025-12-30 | Warnings | 0536-1313 |
| b436ac4b-91da-43d4-9695-b65b7ec0d5e4 | 527b944a-b59e-4e83-86d7-69b852e892db | 2024-11-21 | Warnings | b436ac4b-91da-43d4-9695-b65b7ec0d5e4 527b944a-b59e-4e83-86d7-69b852e892db |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.