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
Dextromethorphan HBr. and Guaifenesin
- Manufacturer
- Everpharm LLC
- Effective date
- 2025-01-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:52:56
Label at a glance#
ProductDextromethorphan HBr. and Guaifenesin
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
DRUG FACTS
10 mg-100 mg/5 mL -
Active ingredient per 5 mL(1 unit dose)
Dextromethorphan HBr. 10 mg
Guaifenesin 100 mg
20 mg-200 mg/10 mL -
Active ingredient per 10 mL(1 unit dose)
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 a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
OTC - DO NOT USE SECTION
Do not useif 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 ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a healthcare professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
Directions
• do not take more than 6 doses in any 24 hour period
20 mg-200 mg/10 mL
| age | dose |
|---|---|
| Children under 12 years of age | Do not use |
| Adults and children over 12 years of age | 10 mL (1 unit dose) every 4 hours |
10 mg-100 mg/5 mL
| age | dose |
| Children under 6 years of age | Do not use |
| Children 6 to under 12 years of age | 5 mL (1 unit dose) every 4 hours |
| Adults and children over 12 years of age | 10 mL (2 unit dose) every 4 hours |
OTHER SAFETY INFORMATION
Other Information
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• do not use if lid is torn or broken
INACTIVE INGREDIENT SECTION
Inactive Ingredientscitric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
OTC - QUESTIONS SECTION
Questions or comments? Call (866) 838-3774
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EverPharm
NDC 84415-014-01
Dextromethorphan HBr.
and Guaifenesin
Oral Solution
Cough Suppressant/
Expectorant
10 mg-100 mg/5 mL
• Alcohol Free
• Sugar Free
• Cherry Flavor
For Institutional Use Only
100 x 5 mL Unit-Dose Cups
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
EverPharm
NDC 84415-011-01
Dextromethorphan HBr.
and Guaifenesin
Oral Solution
Cough Suppressant/
Expectorant
20 mg-200 mg/10 mL
• Alcohol Free
• Sugar Free
• Cherry Flavor
For Institutional Use Only
100 x 10 mL Unit-Dose Cups
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 1 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 1 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 1 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 1 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 1 |
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 |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84415-011-01 | Dextromethorphan HBr. and Guaifenesin | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 1 | |
| 84415-011-01 | Dextromethorphan HBr. and Guaifenesin | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | 1 | |
| 84415-014-01 | Dextromethorphan HBr. and Guaifenesin | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 1 | |
| 84415-014-01 | Dextromethorphan HBr. and Guaifenesin | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 84415-011 | DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [EVERPHARM LLC] | 1 | Current NDC, 2 package rows | 20250119_0c7cd5c4-459d-4e42-ae22-b94f2e29cffb.zip |
| 84415-014 | DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [EVERPHARM LLC] | 1 | Current NDC, 2 package rows | 20250119_0c7cd5c4-459d-4e42-ae22-b94f2e29cffb.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 84415-014-01 | ML - Milliliter | 84415-014 | 694de038-b9ae-4341-a9aa-ffaa1d2a0eee | 1 | 2025-11-13 |
| 84415-011-01 | ML - Milliliter | 84415-011 | 19b6f9aa-f779-40ed-8e43-3be9ebd9a20f | 1 | 2025-11-13 |
Products#
Every source-derived product name is available through these pages.
- Dextromethorphan HBr. and Guaifenesin
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 4
- MENTHOL
- METHYLPARABEN
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84415-014 | 84415-014-01 |
| 84415-011 | 84415-011-01 |
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 |
|---|---|---|---|---|---|---|
| Dextromethorphan HBr. and Guaifenesin | DEXTROMETHORPHAN HBR. AND GUAIFENESIN | Everpharm LLC | 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb | 2025-01-16 | Warnings | 84415-014-01 84415-011-01 84415-014 84415-011 84415001101 84415001401 2bda25ff-9e45-8f8d-e063-6294a90a6a0f 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.