Indications and uses
• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive. • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
elp essential DM
- Manufacturer
- Miramar Cosmetics, Inc DBA Miramar Lab
- Effective date
- 2025-01-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:42:35
Label at a glance#
Productelp essential DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections
Dosage and administration
• Do not take more than 6 doses in any 24-hour period. • Shake well before use. Age Dose Adults and Children 12 years and over 10ml (2 tsps) every 4 hours Children 6 to under 12 years of age. 5ml (1 tsps) every 4 hours Children under 6 years of age Do not use
Storage and handling
• Each 5 ml contains: sodium 8 mg • Store Between 15-30° C (59-86° F) • Tamper Evident Feature Do not use if seal under cap is torn, broken or missing
Label contents#
Full prescribing information#
Active ingredients: (in each 5 ml)
Dextromethorphan HBr USP 10mg
Guaifenesin USP 100mg
Purpose
Cough Suppressant
Expectorant
Uses
• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Warnings
Do not exceed recommended dosage.
Do not use
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychiatric 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 your
doctor or pharmacist before taking this product.
• If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
• Avoid alcoholic beverages while you taking this product.
Ask the doctor before use if you have
• Cough that occurs with too much phlegm (mucus)
• Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Stop use and ask the doctor if
• Nervousness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign serious condition
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.
Directions:
• Do not take more than 6 doses in any 24-hour period.
• Shake well before use.
| Age | Dose |
| Adults and Children 12 years and over | 10ml (2 tsps) every 4 hours |
| Children 6 to under 12 years of age. | 5ml (1 tsps) every 4 hours |
| Children under 6 years of age | Do not use |
Other Information
• Each 5 ml contains: sodium 8 mg
• Store Between 15-30° C (59-86° F)
• Tamper Evident Feature Do not use if seal under cap is torn, broken or missing
Inactive Ingredients
Blue Cohosh, Citric Acid, Echinacea, Eucalyptus Oil, Ginkgo Biloba, Golden Seal Root, Honey Pure, Honey flavor, Horehound Herb, Licorice Root, Menthol, Mullein, Myrrh, Potassium Sorbate, Slippery Elm Bark, Sodium Benzoate, Propylene Glycol, Purified Water, Sodium Chloride, Sucralose, Wild Cherry bark and Zinc Sulfate.
Questions or Comments?
Call Tel 786 6469178
Weekdays from 9:30 AM to 5 PM EST. Time.
SPL UNCLASSIFIED SECTION
New Formula
RELIEVES COUGH CHEST CONGESTION & MUCUS
ALCOHOL FREE
PARABEN FREE
Dextromethorphan & Guaifenesin Plus an ExceptionaL Herbal Blend
With Honey
Distributed by essential products Miami, FI, 33012
Made In U.S.A.
essentialproductsusa.com
Packaging
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- elp essential DM
- Dextromethorphan hydrobromide, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- CAULOPHYLLUM THALICTROIDES ROOT
- CITRIC ACID MONOHYDRATE
- ECHINACEA, UNSPECIFIED
- EUCALYPTUS OIL
- GINKGO
- GOLDENSEAL
- HONEY
- HOREHOUND
- LICORICE
- MENTHOL, UNSPECIFIED FORM
- VERBASCUM THAPSUS WHOLE
- MYRRH
- POTASSIUM SORBATE
- ULMUS RUBRA BARK
- SODIUM BENZOATE
- PROPYLENE GLYCOL
- WATER
- SODIUM CHLORIDE
- SUCRALOSE
- PRUNUS SEROTINA BARK
- ZINC SULFATE, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 79974-204 | 79974-204-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| a2231c12-52f0-4172-baf4-a48cd29a3ce1 | 45d8e640-bfaf-4304-8848-0415e85d7447 | 2025-01-13 | Warnings | a2231c12-52f0-4172-baf4-a48cd29a3ce1 45d8e640-bfaf-4304-8848-0415e85d7447 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.