CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan hbr, guaifenesin suspension

Childrens Cough and Chest Congestion by

Drug Labeling and Warnings

Childrens Cough and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

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

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.

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

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.

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 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

QUESTIONS

Questions? 1-855-436-3921

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*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.

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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

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Made in the USA with globally sourced ingredients

NDC: 69676-0070-9

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

INGREDIENTS AND APPEARANCE

CHILDRENS COUGH AND CHEST CONGESTION 
dextromethorphan hbr, guaifenesin suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
WATER (UNII: 059QF0KO0R)
CITRUS FRUIT (UNII: XDK00Z8012)
BLUEBERRY (UNII: 253RUG1X1A)

Product Characteristics
Color	brown (Golden)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0070-9	1 in 1 CARTON	09/01/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/01/2022

Labeler - Genexa Inc. (079751024)