FDA Label for Kids Cough And Chest Congestion
View Indications, Usage & Precautions
Kids Cough And Chest Congestion 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.
Bottle is safety sealed with a perforated band around the bottle. DO NOT use if bottle seal is disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30068 | genexa.com
*This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US)
LLC, owner of the registered trademark Children’s
Robitussin® Cough & Chest Congestion DM.
Made in the USA with globally sourced ingredients
NDC 69676-0085-9
Otc - Active Ingredient
Active ingredients (in each 5 mL)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Otc - Purpose
Purposes
Cough suppressant
Expectorant
Indications & Usage
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Warnings
Otc - Do Not Use
Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
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.
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
SHAKE WELL BEFORE USING
- do not give more than 6 doses in any 24-hour period
- use only with enclosed dose cup. Do not use with any other dosing device.
- mL = milliliter
| children 6 to under 12 years | 5 mL - 10 mL every 4 hours |
| children 4 to under 6 years | 2.5 mL - 5 mL every 4 hours |
| children under 4 years | do not use |
Directions
Added "SHAKE WELL BEFORE USING" under Directions
Storage And Handling
Other information
store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredientsorganic agave syrup, organic cherry flavor, natural citrus extract, natural flavor, purified water
Otc - Questions
Questions?
1-855-436-3921
Package Label.Principal Display Panel
Genexa®
MEDICINE MADE CLEAN
Ages 4-11
Kids' Cough & Chest Congestion
Dextromethorphan HBr | Guaifenesin
Cough Suppressant - Expectorant
Cough
Mucus
Chest Congestion
Made with the same active ingredients as Children’s
Robitussin® Cough & Chest Congestion DM*
Medicine made clean
Same effective active ingredients,
but no artificial fillers.
Organic Cherry Flavor
4 FL OZ (118 mL)
Dosing cup included
* Please review the disclaimer below.