CVS DEX-DOX KIDS NIGHTTIME COUGH SUPPRESSANT- dextromethorphan hbr chewable gel

CVS Dex-Dox Kids Nighttime Cough Suppressant by

Drug Labeling and Warnings

CVS Dex-Dox Kids Nighttime Cough Suppressant by is a Otc medication manufactured, distributed, or labeled by CVS, SCNBestco, SCN Bestco. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

PURPOSE

Purpose

Cough suppressant

Antihistamine

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• controls cough to help you sleep
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• itching of the nose and throat
• sneezing
• itchy, watery eyes

WARNINGS

Warnings

Do not use

• to make a child sleep
• 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 week after stopping an MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have

• a sodium-restricted diet
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• cough accompanied by excessive phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

WHEN USING

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• exciteability may occur, expecially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drings
• use caution when driving a motor vehicle or operating machinery

STOP USE

Stop use and ask doctor if

• cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• take every 4 hours or as directed by a doctor
• chew thoroughly before swallowing

adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period

children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period

children ages 6 and under - do not use

OTHER SAFETY INFORMATION

Other information

• each chewable tablet contains: potassium 5 mg and sodium 15 mg
• store in a cool dry place at 20° - 25°C (68° - 77°F)

INACTIVE INGREDIENT

Inactive ingredients: Anhydrous citric acid, corn syrup, cranberry juice concentrate, FD&C Blue #1, FD&C Red #40, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.

QUESTIONS

Questions? 1-800-245-2898, Monday - Friday, 9AM - 4PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS DEX-DOX KIDS NIGHTTIME COUGH SUPPRESSANT 
dextromethorphan hbr chewable gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-081
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	25mm
Flavor	BERRY	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-081-16	16 in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/04/2025

Labeler - CVS (062312574)

Registrant - SCNBestco (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
SCN Bestco		002149136	manufacture(51316-081)