FDA Label for Childrens Cough And Chest Congestion
View Indications, Usage & Precautions
Childrens 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
*This product is not manufactured or distributed by PF CONSUMER HEALTHCARE 1 LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Atlanta, GA 30318 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0070-9
Otc - Active Ingredient
Active ingredients
(in each 5 mL)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg
Otc - Purpose
Purpose
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.
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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
(1-800-222-1222)
Dosage & Administration
Directions
- 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 |
Storage And Handling
Other information
store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
organic agave syrup, organic blueberry flavor, natural citrus extract, flavor, purified water
Otc - Questions
Questions? 1-855-436-3921
Package Label.Principal Display Panel
Children's
Genexa®
MEDICINE MADE CLEAN
Ages 4-11
Cough & Chest Congestion
Dextromethorphan HBr | Guaifenesin
Cough Suppressant - Expectorant
Mucus
Chest Congestion
Compare to active ingredients in Children's Robitussin® Cough & Chest Congestion DM*
How we're different
Made without: sodium benzoate, propylene glycol, sucralose & more!
Organic Blueberry Flavor
4 fl oz (118 mL) Dosing cup included
* Please review the disclaimer below.
