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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2683423 | dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable Tablet | PSN | 1 |
| 2683423 | dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Chewable Tablet | SCD | 1 |
| 2683423 | dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Chewable Tablet | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-081-16 | CVS Dex-Dox Kids Nighttime Cough Suppressant | 16 in 1 BOTTLE | CHEWABLE GEL | 16 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- CVS Dex-Dox Kids Nighttime Cough Suppressant
- Dextromethorphan HBr
- WATER
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-081 | 51316-081-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CVS Dex-Dox Kids Nighttime Cough Suppressant | DEXTROMETHORPHAN HBR | CVS | 2f8b6f5e-399c-b033-e063-6294a90ac3d1 | 2025-03-04 | Warnings | 51316-081-16 51316-081 51316008116 2f8b6f5e-399d-b033-e063-6294a90ac3d1 2f8b6f5e-399c-b033-e063-6294a90ac3d1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
