Cvs Health Non-drowsy Children’s Daytime & Night-time Cough And Chest Congestion Dm

Cvs Health Non-drowsy Children’s Daytime & Night-time Cough And Chest Congestion Dm
SPL v6
SPL
SPL Set ID 347f1731-5b85-4220-ae2b-9497a3afa4ed
Route
ORAL
Published
Effective Date 2019-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum Potassium Sorbate

Identifiers & Packaging

Pill Appearance
Color: purple Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-19

Description

Dextromethorphan HBr USP 5 mg Guaifenesin. USP 100 mg

Purpose

Antihistamine Cough suppressant


Medication Information

Purpose

Antihistamine Cough suppressant

Description

Dextromethorphan HBr USP 5 mg Guaifenesin. USP 100 mg

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
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.
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

Purposes for Day Time

Cough suppressant

Expectorant

Purpose for Night Time

Antihistamine

Cough suppressant

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

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

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
Active Ingredients Day Time (in Each 5 Ml)

Dextromethorphan HBr USP 5 mg

Guaifenesin. USP 100 mg

Ask A Doctor Or Pharmacist Before Use If You Are

NIGHTTIME

taking sedatives or tranquilizers.

Active Ingredients for Nighttime (in Each 10 Ml)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr USP 15 mg


Structured Label Content

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
Do Not Us (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.
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 (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)

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

Purposes for Day Time

Cough suppressant

Expectorant

Purpose for Night Time

Antihistamine

Cough suppressant

Questions Or Comments? (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

When Using This Product (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 (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, (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. (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

Ask A Doctor Before Use If You Have (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
Active Ingredients Day Time (in Each 5 Ml) (Active ingredients Day Time (in each 5 mL))

Dextromethorphan HBr USP 5 mg

Guaifenesin. USP 100 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

NIGHTTIME

taking sedatives or tranquilizers.

Active Ingredients for Nighttime (in Each 10 Ml) (Active ingredients for Nighttime (in each 10 mL))

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr USP 15 mg


Advanced Ingredient Data


Raw Label Data

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