CVS PHARMACY COLD AND COUGH AND NIGHTTIME VALUE PACK- brompheniramine maleate,dextromethorphan hbr,diphenhydramine hcl kit

CVS PHARMACY by

Drug Labeling and Warnings

CVS PHARMACY by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

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

Diphenhydramine HCL12.5 mg

Purposes for Children’s Cold & Cough

Antihistamine

Cough suppressant

Purposes for Children’s Nighttime Cold & Cough

Antihistamine/Cough suppressant

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)
  • ▪ relieves the impulse to cough to help you sleep.

Warnings Do not use

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

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

Cold & Cough

taking sedatives or tranquilizers

Nighttime Cold & Cough

taking sedatives or tranquilizers

When using this product

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

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.

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,

Ask a health professional before use

Directions

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

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 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?

1-866-467-2748

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

INGREDIENTS AND APPEARANCE

CVS PHARMACY  COLD AND COUGH AND NIGHTTIME VALUE PACK
brompheniramine maleate,dextromethorphan hbr,diphenhydramine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-635

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-635-08	1 in 1 KIT; Type 0: Not a Combination Product	03/03/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	118 mL
Part 2	1 BOTTLE, PLASTIC	118 mL

Part 1 of 2

CVS PHARMACY  CHILDRENS COLD AND COUGH
brompheniramine maleate, dextromethorphan hbr liquid

Product Information
Item Code (Source)	NDC: 51316-632
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-632-04	118 mL in 1 BOTTLE, PLASTIC; 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	03/03/2025

Part 2 of 2

CVS PHARMACY  CHILDRENS NIGHTTIME COLD AND COUGH
diphenhydramine hcl liquid

Product Information
Item Code (Source)	NDC: 51316-646
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-646-04	118 mL in 1 BOTTLE, PLASTIC; 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	03/03/2025

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

Labeler - CVS PHARMACY, INC. (062312574)