Label: DAYTIME AND NIGHTTIME COUGH AND CHEST CONGESTION CHILDRENS- dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit
- NDC Code(s): 69842-657-08
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 22, 2024
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- Active ingredients Day Time (in each 5 mL)
- Active ingredients for Nighttime (in each 10 mL)
- Purposes for Day Time
- Purpose for Night Time
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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
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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
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.
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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
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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?
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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
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Money Back Guarantee
-
INGREDIENTS AND APPEARANCE
DAYTIME AND NIGHTTIME COUGH AND CHEST CONGESTION CHILDRENS
dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kitProduct 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 liquidProduct 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 Drug M012 02/19/2019 Part 2 of 2 NIGHT TIME COUGH DM FRUIT PUNCH
chlorpheniramine maleate, diphenhydramine hbr liquidProduct 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 Drug M012 02/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/19/2019 Labeler - CVS Pharmacy (062312574)
