Storage and handling
Other information store between 20-25°C (68-77°F) do not refrigerate
Cough and Chest Congestion Maximum Strength
- Manufacturer
- Genexa Inc.
- Effective date
- 2025-06-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:03:51
Label at a glance#
ProductCough and Chest Congestion Maximum Strength
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Patent Pending | Distributed by:
Genexa Inc. Atlanta, GA 30324
genexa.com
NDC 69676-0077-9
SPL UNCLASSIFIED SECTION
Do not use if inner seal is disturbed or missing.
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
OTC - PURPOSE SECTION
Purpose
Cough suppressant
Expectorant
INDICATIONS & USAGE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help you get to sleep
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
PREGNANCY 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 (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions
SHAKE WELL BEFORE EACH USE
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
STORAGE AND HANDLING SECTION
Other information
- store between 20-25°C (68-77°F)
- do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural flavors, purified water
OTC - QUESTIONS SECTION
Questions?
1-855-436-3921
SPL UNCLASSIFIED SECTION
SHAKE WELL BEFORE EACH USE.
Made in the USA with globally sourced ingredients
RECENT MAJOR CHANGES SECTION
Directions
SHAKE WELL BEFORE EACH USE
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Genexa ®
MEDICINE
MADE CLEAN
Maximum Strength
Cough & Chest Congestion
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Cough
Mucus
Chest Congestion
Medicine made clean
Same effective active ingredients, but no artificial fillers.
Organic Blueberry Flavor
6 fl oz (177 mL)
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69676-0077-9 | 2024-02-12 | C162847 | 48780-1 | 1030e365-408c-111a-e063-dadaa90a10e2 | Cough and Chest Congestion Maximum Strength |
| 69676-0077-9 | 2024-01-30 | C162847 | 48780-1 | 1030e365-408c-111a-e063-dadaa90a10e2 | Cough and Chest Congestion Maximum Strength |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0077-9 | Cough and Chest Congestion Maximum Strength | 177 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 177 | 7 |
Products#
Every source-derived product name is available through these pages.
- Cough and Chest Congestion Maximum Strength
- Dextromethorphan HBr, Guaifenesin
- GUAIFENESIN
- AGAVE TEQUILANA JUICE
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- BLUEBERRY
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0077 | 69676-0077-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| AGAVE TEQUILANA JUICE | GVG8G0207O | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| BLUEBERRY | 253RUG1X1A | 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 |
|---|---|---|---|---|---|---|
| Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Genexa Inc. | 18835205-a9e3-15c2-e063-6394a90a8107 | 2025-07-02 | Warnings | 69676-0077-9 69676007709 |
| Cough and Chest Congestion Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | e920b700-30d3-3266-e053-2a95a90a0639 | 2025-06-24 | Warnings | 69676-0077-9 69676-0077 69676007709 3857582e-3b04-90e9-e063-6294a90ab3d9 e920b700-30d3-3266-e053-2a95a90a0639 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.