Indications and 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 drain bronchial tubes
Guaifenesin DM
- Manufacturer
- Pharmaceutical Associates, Inc.
- Effective date
- 2010-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:53:11
Label at a glance#
ProductGuaifenesin DM
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN
Label structure7 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each 5 mL teaspoonful) | Purposes |
| Guaifenesin 200 mg | Expectorant |
| Dextromethorphan HBr 10 mg | Cough Suppressant |
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 drain bronchial tubes
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.
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
OTC - STOP USE SECTION
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- do not take more than 6 doses in any 24-hour period
age dose adults and children 12 years and over 10 mL (2 teaspoonsful) every 4 hours children 6 to under 12 years of age 5 mL (1 teaspoonful) every 4 hours children 2 to under 6 years of age 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years consult a doctor
Other information
- each teaspoonful contains: sodium 4 mg
- store at 20° - 25°C (68° - 77°F)
- alcohol/sugar free
- red, cherry flavored solution supplied in the following oral dosage forms: NDC 0121-0809-04 (4 fl oz bottle), NDC 0121-0809-08 (8 fl oz bottle), NDC 0121-4809-05 (unit dose cups of 5 mL, packaged in trays of 10), and NDC 0121-4809-10 (unit dose cups of 10 mL, packaged in trays of 10).
Inactive ingredients
Acesulfame K, citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol and sucralose.
Questions or comments?
Call 1-800-845-8210. You may also report serious side effects to this phone number.
PRINCIPAL DISPLAY PANEL - 118 mL Label
NDC 0121-0809-04
Quality®
Value
Maximum Strength
Guaifenesin DM
Cough & Chest
Congestion
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
ALCOHOL / SUGAR FREE
Relieves Cough /
Maximum Strength
Mucus Relief
4 fl oz (118 mL)
PRINCIPAL DISPLAY PANEL - 5 mL Lid
Delivers 5 mL
NDC 0121-4809-05
MAXIMUM STRENGTH
GUAIFENESIN DM
Guaifenesin (Expectorant)
Dextromethorphan HBr (Cough Suppressant)
200 mg/10 mg per 5 mL
Alcohol Free / Sugar Free
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-0809-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c687-621f-e053-dbdaa90a74ad | Maximum Strength Guaifenesin DM Non-Narcotic, Sugar and Alcohol Free Expectorant/Cough Suppressant |
| 0121-0809-08 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c687-621f-e053-dbdaa90a74ad | Maximum Strength Guaifenesin DM Non-Narcotic, Sugar and Alcohol Free Expectorant/Cough Suppressant |
| 0121-4809-05 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c687-621f-e053-dbdaa90a74ad | Maximum Strength Guaifenesin DM Non-Narcotic, Sugar and Alcohol Free Expectorant/Cough Suppressant |
| 0121-4809-10 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c687-621f-e053-dbdaa90a74ad | Maximum Strength Guaifenesin DM Non-Narcotic, Sugar and Alcohol Free Expectorant/Cough Suppressant |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN | ACTIVE INGREDIENT | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin DM
- GUAIFENESIN and DEXTROMETHORPHAN
- GUAIFENESIN
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0121-0809 | 0121-0809-08, 0121-0809-04 |
| 0121-4809 | 0121-4809-05, 0121-4809-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN | 7355X3ROTS | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN | 7355X3ROTS | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 58f894c7-263c-433a-af8d-7073c7079917 | 990eef79-5380-48c6-8b8f-d4814e0fd293 | 2010-02-01 | Warnings | 58f894c7-263c-433a-af8d-7073c7079917 990eef79-5380-48c6-8b8f-d4814e0fd293 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.