Indications and uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
DR. SANA COUGH AND CHEST CONGESTION DM
- Manufacturer
- GADAL Laboratories, Inc
- Effective date
- 2025-07-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:08:28
Label at a glance#
ProductDR. SANA COUGH AND CHEST CONGESTION DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections
Dosage and administration
do not exceed more than 6 doses in any 24-hour period shake well before use mL=milliliter age dose adults and children 12 years & more 2 tablespoons (30 mL) every 4 hours children under 12 years of age consult your doctor
Storage and handling
• Store this product between 15°C to 30°C (59° to 86°F) • Tamper evident feature: Do not use this product if imprinted cello-band over cap is torn, broken or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients: (in each 30ml)
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Purpose
Cough Suppressant
Expectorant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and 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.
Ask a doctor before use if you have • a cough that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding, ask 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.
Directions:
do not exceed more than 6 doses in any 24-hour period
shake well before use
mL=milliliter
| age | dose |
| adults and children 12 years & more | 2 tablespoons (30 mL) every 4 hours |
| children under 12 years of age | consult your doctor |
Other information
• Store this product between 15°C to 30°C (59° to 86°F)
• Tamper evident feature: Do not use this product if imprinted cello-band over cap is torn, broken or missing.
Inactive ingredients:
Aloe Vera, Citric Acid, Caramel Color, Corn Syrup, Eucalyptus Oil, Ginger Root PE, Honey, Natural and Artificial Honey Flavor, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sodium Benzoate, Sucralose, Xanthan Gum.
Questions?
call Weekdays from 9:30 AM to 5 PM EST at Tel. 305-633-7900
SPL UNCLASSIFIED SECTION
Relieves:
• COUGH
• CHEST CONGESTION
with Natural Ingredients
• ALOE
• HONEY
• GINGER
• EUCALYPTUS
NON DROWSY • NO GLUTEN
Distributed by:
Healthtex Distributors, LLC
Miami, Florida 33142
info@healthtexusa.com
Made in USA
TAMPER EVIDENT FEATURE: DO NOT USE THIS PRODUCT IF IMPRINTED CELLO-BAND OVER CAP IS TORN BROKEN OR MISSING
Packaging
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2719927 | dextromethorphan hydrobromide 20 MG / guaiFENesin 200 MG in 30 mL Oral Suspension | PSN | 2 |
| 2719927 | dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.667 MG/ML Oral Suspension | SCD | 2 |
| 2719927 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 mL Oral Suspension | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53113-514-06 | DR. SANA COUGH AND CHEST CONGESTION DM | 180 mL in 1 BOTTLE | LIQUID | 180 | 2 | |
| 53113-514-06 | DR. SANA COUGH AND CHEST CONGESTION DM | 1 in 1 BOX | LIQUID | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- DR. SANA COUGH AND CHEST CONGESTION DM
- Dextromethorphan Hydrobromide, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ALOE VERA LEAF
- CITRIC ACID MONOHYDRATE
- CARAMEL
- CORN SYRUP
- EUCALYPTUS OIL
- GINGER
- HONEY
- MENTHOL, UNSPECIFIED FORM
- METHYLPARABEN
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM BENZOATE
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53113-514 | 53113-514-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| CARAMEL | T9D99G2B1R | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| GINGER | C5529G5JPQ | IACT |
| HONEY | Y9H1V576FH | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|
| DR. SANA COUGH AND CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | baca0580-4c30-4b94-89fa-a7cf06d4ff25 | 2025-07-22 | Warnings | 53113-514-06 53113-514 53113051406 1c455366-014d-49d6-b502-caec4942f777 baca0580-4c30-4b94-89fa-a7cf06d4ff25 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.