DAYTIME AND NIGHTTIME COUGH AND CHEST CONGESTION CHILDRENS- dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit

Daytime and Nighttime Cough and Chest Congestion by

Drug Labeling and Warnings

Daytime and Nighttime Cough and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients Day Time (in each 5 mL)

Dextromethorphan HBr USP 5 mg

Guaifenesin. USP 100 mg

Active ingredients for Nighttime (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr USP 15 mg

Purposes for Day Time

Cough suppressant

Expectorant

Purpose for Night Time

Antihistamine

Cough suppressant

Uses

DAYTIME

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

NIGHTTIME

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

Warnings

Do not us

DAYTIME

• 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

NIGHTTIME

• 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

DAYTIME

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

NIGHTTIME

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

Ask a doctor or pharmacist before use if you are

NIGHTTIME

taking sedatives or tranquilizers.

When using this product

NIGHTTIME

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

DAYTIME

• cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

NIGHTTIME

• cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

DAYTIME

ask a health professional before use.

NIGHTTIME

ask a health professional before use

Keep out of reach of children.

DAYTIME

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

NIGHTTIME

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

Directions

DAYTIME

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

• age:

  dose

• Children under 4 years:

  Do not use

• Children 4 to under 6 years:

  5 mL every 4 hours

• Children 6 to under 12 years:

  10 mL every 4 hours

• Adults and children 12 years and older:

  20 mL every 4 hours

NIGHTTIME

• measure only with dosing cup provided.
• keep dosing cup with product
• mL= milliliter
• do not take more than 4 doses in any 24-hour period

• age:

  dose

• Children under 6 years:

  Do not use

• Children 6 to under 12 years:

  10 mL every 6 hours

• Adults and children 12 years and older:

  20 mL every 6 hours

Other information

DAYTIME

• each 5 mL contains: sodium 3 mg
• store at room temperature. Do not refrigerate
• contain low sodium
• do not use if printed seal under cap is torn or missing

NIGHTTIME

• each 10 mL contains: sodium 3 mg
• store at room temperature. Do not refrigerate
• contain low sodium
• do not use if printed seal under cap is torn or missing

Inactive ingredients

Inactive ingredients for Day Time 

anhydrous citric acid, edetate disodium, FD &C Blue # 1, FD&C Red # 40, natural and artificial flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Inactive ingredients for Night Time 

anhydrous citric acid, FD&C Red # 40, natural and artificial flavors, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Children's Robitussin® Cough & Chest Congestion DM*

Non-Drowsy

Children's

Cough & Chest Congestions DM

Each 5 mL dose of oral solution contains:

DEXTROMETHORPHAN HBr, USP 5 mg

Cough suppressant

GUAIFENESIN, USP 100 mg

Expectorant

Relieves

• Chest congestion/mucus
• Cough

For Ages 4 and over

Grape Flavor

Naturally and Artificially Flavored

Dosage cup included

TWO 4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)

Compare to the active ingredients in Children's Robitussin® Nighttime Cough DM*

NDC# 69842-657-08

Children's

Nighttime Cough DM

Each 10 mL dose of oral solution contains:

CHLORPHENIRAMINE MALEATE, USP 2 mg

Antihistamine

DEXTROMETHORPHAN HBr, USP 15 mg

Cough suppressant

Relieves

• Cough up to 8 hours
• Runny nose

Alcohol free

For Ages 6 & over

Fruit Punch Flavor

Naturally and Artificially Flavored

Dosage cup included

TWO 4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)

*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin® Cough + Chest Congestion DM and Children’s Robitussin® Nighttime Cough DM.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2018 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-12431

CVS® Quality

Money Back Guarantee

INGREDIENTS AND APPEARANCE

DAYTIME AND NIGHTTIME COUGH AND CHEST CONGESTION  CHILDRENS
dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-657

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-657-08	1 in 1 KIT; Type 0: Not a Combination Product	02/19/2019

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

Part 1 of 2

DAYTIME COUGH AND CHEST CONGESTION  GRAPE FLAVOR
dextromethorphan hbr, guaifenesin liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/19/2019

Part 2 of 2

NIGHT TIME COUGH DM  FRUIT PUNCH
chlorpheniramine maleate, diphenhydramine hbr liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/19/2019

Labeler - CVS Pharmacy (062312574)