The following Structured Product Label (SPL) was submitted to the FDA by Genexa for the product Nighttime Cough-kids (NDC 69676-0088). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
* This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,
owner of the registered trademark Children’s
Robitussin® Nighttime Cough Long-Acting DM.
SHAKE WELL before each use.
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 30324 | genexa.com
Made in the USA with globally sourced ingredients
NDC 69676-0088-9
Active ingredients (in each 10 mL)
Chlorpheniramine maleate, USP 2 mg
Dextromethorphan HBr, USP 15 mg
Purposes
Antihistamine
Cough suppressant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Warnings
Do not use
• to sedate a child or make a child sleepy
• 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
Ask a doctor before use if you have
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts
or as occurs with smoking, asthma, chronic bronchitis
or emphysema
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
• Do not use more than directed
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever,
rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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).
Directions
• SHAKE WELL BEFORE USING
• measure only with dosing cup provided
• keep dosing cup with product • mL = milliliter
• do not take more than 4 doses in any 24-hour period
| Age | Dose |
Adults and children 12 years and older | 20 mL every 6 hours |
Children 6 to under 12 years | 10 mL every 6 hours |
Children under 6 years | do not use |
Other information
store between 20-25°C (68-77°F)
Inactive ingredients
organic agave syrup, organic blueberry flavor,
natural citrus extract, natural flavor, purified water
Questions? 1-855-436-3921
Genexa®
MEDICINE MADE CLEAN
Ages 6+
Long Acting
Kids' Nighttime Cough
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr- Cough Suppressant
Relieves Cough up to 8 Hours
Runny Nose
Sneezing
Made with the same active ingredients as Children’s
Robitussin® Nighttime Cough Long-Acting DM*
Medicine made clean
Same effective active ingredients,
but no artificial fillers.
Organic Blueberry Flavor
4 fl oz (118 mL)
Dosing cup included
* Please review the disclaimer below.
