FDA Label for Cough And Chest Congestion Maximum Strength
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- PREGNANCY
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cough And Chest Congestion Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Genexa Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
SHAKE WELL before each use.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318
genexa.com
Made in the USA with globally sourced ingredients
Otc - Active Ingredient
Active ingredients (in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Otc - Purpose
Purposes
Cough suppressant
Expectorant
Indications & Usage
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
Warnings
Otc - Do Not Use
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
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
When using this product do not use more than directed
Otc - Stop Use
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
Directions
- 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
Other information
- store between 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredient
Inactive ingredients organic agave syrup, natural citrus extract, natural flavor, purified water
Otc - Questions
Questions?
1-855-436-3921
Package Label.Principal Display Panel
Genexa
MEDICINE MADE CLEAN
Maximum Strength Cough & Chest Congestion
Dextromethorphan HBr | Guaifenesin
Cough Suppressant - Expectorant
Made without
FD&C red no. 40, propylene glycol,
sorbitol & other artificial fillers!
Blueberry Flavor
6 fl oz (177 mL)
Dosing cup included
* Please review the disclaimer below.