Label: DAYTIME AND NIGHTTIME COUGH AND CHEST CONGESTION CHILDRENS- dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit
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- NDC Code(s): 69842-657-08
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 29, 2022
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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
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- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
NIGHTTIME
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- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- runny nose
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- sneezing
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- itching of the nose or throat
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- 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
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- 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
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
NIGHTTIME
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- trouble urinating due to an enlarges prostate gland
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- glaucoma
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- a cough that occurs with too much phlegm (mucus)
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- 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
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- 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.
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- 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
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- contain low sodium
- •
- do not use if printed seal under cap is torn or missing
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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
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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®
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Money Back Guarantee
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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 final part341 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 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)
