CVS Dex-Dox Kids Nighttime Cough Suppressant

Manufacturer
CVS | SCNBestco | SCN Bestco
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:42

Label at a glance#

ProductCVS Dex-Dox Kids Nighttime Cough Suppressant
Active ingredientDOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant

Antihistamine

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Dex Dox Kids Nighttime 16ct Cough SuppressantCVS Dex Dox Kids Nighttime 16ct Cough Suppressant

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletPSN1
2683423dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable TabletSCD1
2683423dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-081-16CVS Dex-Dox Kids Nighttime Cough Suppressant16 in 1 BOTTLECHEWABLE GEL161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-081CVS DEX-DOX KIDS NIGHTTIME COUGH SUPPRESSANT (DEXTROMETHORPHAN HBR) CHEWABLE GEL [CVS]1Current NDC, 1 package rows20250308_2f8b6f5e-399c-b033-e063-6294a90ac3d1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-08151316-081-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
ndc (package): 51316-081-16
ndc (product): 51316-081
ndc11 (package): 51316008116
spl id: 2f8b6f5e-399d-b033-e063-6294a90ac3d1
spl set id: 2f8b6f5e-399c-b033-e063-6294a90ac3d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.