CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK

Manufacturer
CVS PHARMACY, INC.
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:01:56

Label at a glance#

ProductCVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK
Active ingredientBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

Cold & Cough ▪ temporarily relieves ▪ runny nose ▪ cough ▪ sneezing ▪ itching of the nose or throat ▪ itchy, watery eyes due to hay fever (or other upper respiratory allergies) ▪ temporarily alleviates the intensity of coughing Nighttime Cold & Cough ▪ temporarily relieves ▪ runny nose ▪ cough ▪ sneezing ▪ itching of the nose or throat ▪ itchy, watery eyes due to hay fever (or other upper respiratory allergies) ▪ ...

Dosage and administration

Cold & Cough ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided. ▪ Keep dosage cup with product ▪ mL= milliliter age dose Adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use Nighttime cold & cough ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup pro...

Storage and handling

Cold & cough ▪ each 10 mL contains: sodium 6 mg ▪ store at room temperature. Nighttime cold & cough ▪ each 10 mL contains: sodium 6 mg ▪ store at room temperature.

Label contents#

Full prescribing information#

Children’s Cold & Cough Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Children’s Nighttime Cold & Cough Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL12.5 mg

Purposes for Children’s Cold & Cough

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Purposes for Children’s Nighttime Cold & Cough

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Cold & Cough

  • temporarily relieves
    • runny nose
    • cough
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • temporarily alleviates the intensity of coughing

Nighttime Cold & Cough

  • temporarily relieves
    • runny nose
    • cough
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • relieves the impulse to cough to help you sleep.

Warnings Do not use

WARNINGS SECTION

Cold & Cough

  • to sedate a child or to 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Nighttime Cold & Cough

  • to sedate a child or to make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Cold & Cough

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Nighttime Cold & Cough

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Cold & Cough

taking sedatives or tranquilizers

Nighttime Cold & Cough

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

Cold & Cough

  • do not use more than directed.
  • may cause marked drowsiness
  • 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

Nighttime cold & cough

  • do not use more than directed.
  • may cause marked drowsiness
  • 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

OTC - STOP USE SECTION

Cold & Cough

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.

Nighttime cold & cough

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Cold & Cough

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

Nighttime Cold & Cough

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION

Cold & Cough

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • Keep dosage cup with product
  • mL= milliliter

age

dose

Adults and children 12 years and over

20 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

children under 6 years

do not use


Nighttime cold & cough

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • Keep dosage cup with product
  • mL= milliliter

age

dose

 Adults and children 12 years and over

 20 mL every 4 hours

 children 6 to under 12 years

10 mL every 4 hours

 children under 6 years

do not use

Other information

STORAGE AND HANDLING SECTION

Cold & cough

  • each 10 mL contains: sodium 6 mg
  • store at room temperature.

Nighttime cold & cough

  • each 10 mL contains: sodium 6 mg
  • store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients for Cold & Cough 

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Inactive ingredients for Nighttime 

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

Children's

Cold & Cough

Brompheniramine Maleate (Antihistamine),

Dextromethorphan HBr (Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

For Ages 6 Years and over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

Compare to the active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**

Children's Nighttime

Cold & Cough

Diphenhydramine HCI (Antihistamine / Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

For Ages 6 Years and over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

2-4 FL OZ (118 mL) BOTTLES/TOTAL 8 FL OZ (236 mL)

Do not take both products at the same time. Always wait at least 4 hours before taking another dose of the product.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE FOR FULL LABELING

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Cold & Cough.

**This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Nighttime Cold & Cough.

Distributed by:

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Children's Cold & Cough & Nightime Cold & Cough Value pack
CVS Children's Cold & Cough & Nightime Cold & Cough Value pack

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-63551316-635-08
51316-63251316-632-04
51316-64651316-646-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-10full-release2026-06-01 01:21:39

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 PHARMACY COLD and COUGH And NIGHTTIME VALUE PACKBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCLCVS PHARMACY, INC.4d94968b-ada3-4344-8563-cba7fc491d742026-08-19WarningsExact identifier
ndc (package): 51316-635-08
ndc (package): 51316-632-04
ndc (package): 51316-646-04
ndc (product): 51316-635
ndc11 (package): 51316063508
ndc11 (package): 51316063204
ndc11 (package): 51316064604
spl id: 18c65cf1-b3d8-4764-8b5d-d77ea642df5d
spl set id: 4d94968b-ada3-4344-8563-cba7fc491d74

Reported adverse events (FAERS/openFDA)#

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