Guaifed DM
- Manufacturer
- Aldama Pharmaceuticals, Inc
- Effective date
- 2026-08-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-08-12 01:01:17
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:( per 10ml= 2 teaspoonfuls) Purpose
Guaifenesin 200 mg ................................................................... Expectorant
Dextromethorphan 20mg............................................................ Cough Suppresant
OTC - PURPOSE SECTION
Purpose
Expectorant
Cough Suppresant
INDICATIONS & USAGE SECTION
Uses:
- Temporarily relieves coiugh due to minor throat and bronchial irritation
- Helps loosen phlegm (mucus)
- helps thin bronchial secretions to make coughs more productive.
WARNINGS SECTION
Warnings
- Do not use:if you are now takin a prescription monoamine oxidase inhibidor (MAOI) (certain drugs for deression, psychiatric or emotional conditions, or Parkinson's disease, or for two weeks after stoping the MAOI drug. If you do not know if nyour prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not exceed recommended dosage
- take every 4 hours as needed, or as directed by doctor
- do not take more than 6 doses in 24 hours
| Age | Dose |
| adults and children 12 years and over | 10 mL (2 teaspoonfuls) |
| children under 12 years | Do not use |
OTHER SAFETY INFORMATION
Other information
- each 10 mL contains:potassium 20 mg
- TAMPER - EVIDENT FEATURE:Do not use if foil seal over bottle opening is torn, broken or missing.
- store between 15° - 30°C (59° - 86°F).
- Protect from freezing
- protect from light
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Artificial and natural cherry flavor, citric acid, menthol, Methylparaben, Propylene glycol, Propylparaben, purified water, sodium citrate, sucralose
OTC - QUESTIONS SECTION
Questions or Comments?305-592-9216 or info@aldamapharm.com
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Guaifed DM
DailyMed Product Concepts#
| 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 |
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73564-802-04 | ML - Milliliter | 73564-802 | b5e038d5-aea0-4747-8a78-6f99214f3514 | 1 | 2025-09-12 |
| 73564-802-08 | ML - Milliliter | 73564-802 | 367cc6af-2360-46b4-90f3-92561199a93d | 1 | 2025-09-12 |
| 73564-802-16 | ML - Milliliter | 73564-802 | ed44ff26-9142-4725-8d3d-3cf1e3d86c88 | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- Guaifed DM
- Dextromethorphan, Guaifenesin
- GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- MENTHOL
- METHYLPARABEN
- PROPYLENE GLYCOL
- WATER
- SODIUM CITRATE
- CITRIC ACID
- SUCRALOSE
- PROPYLPARABEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73564-802 | 73564-802-16, 73564-802-08, 73564-802-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2026-05-15 | daily-update | 2026-06-03 18:04:10 |
| 4 | 2025-10-14 | full-release | 2026-06-01 01:38:54 |
| 3 | 2025-08-06 | full-release | 2026-06-01 01:09:26 |
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 |
|---|---|---|---|---|---|---|
| Guaifed DM | DEXTROMETHORPHAN, GUAIFENESIN | Aldama Pharmaceuticals, Inc | 396bf716-0f61-9563-e063-6394a90a171b | 2026-08-10 | Warnings | 73564-802-16 73564-802-08 73564-802-04 73564-802 73564080208 73564080204 73564080216 58b4e715-186f-6cc6-e063-6294a90af150 396bf716-0f61-9563-e063-6394a90a171b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
