Cvs Nighttime Children's Cold & Cough Relief

Cvs Nighttime Children's Cold & Cough Relief
SPL v5
SPL
SPL Set ID d66b1a2e-49b6-473b-acec-2694c73ce8b4
Route
ORAL
Published
Effective Date 2023-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Dextromethorphan (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Potassium Citrate Potassium Sorbate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-20

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves cold symptoms:

  • cough due to minor throat & bronchial irritation
  • sneezing
  • runny nose
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients

(in each 15 mL)
Purpose

Chlorpheniramine maleate 2 mg

Antihistamine

Dextromethorphan HBr 15 mg

Cough suppressant

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hrs.
  • only use the dose cup provided

adults & children 12 yrs & over

30 mL every 6 hrs.

children 6 to under 12 yrs

15 mL every 6 hrs.

children 4 to under 6 yrs

do not use unless directed by a doctor

children under 4 yrs

do not use

Do Not Use
  • 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.
  • to make a child sleepy
Other Information
  • each 15 mL contains:potassium 5 mg, sodium 5 mg
  • sugar free
  • aspirin free
  • store at room temperature
Inactive Ingredients

anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions Or Comments?

1-866-467-2748

When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Principal Display Panel 236 Ml Bottle Label

Compare to the active ingredients in Children’s Vicks Nyquil™ Cold & Cough*

NDC 51316-752-08

Nighttime

Childrens

Cold & Cough

Chlorpheniramine maleate 2 mg,

Dextromethorphan HBr 15 mg

  • Sneezing
  • Runny Nose
  • Cough

No Added Alcohol, Acetaminophen Free

Berry Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

DISTRIBUTED BY:

TAMPER EVIDENT:Do not use if printed shrink band is missing or broken.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks ®Nyquil™ Cold & Cough.


Structured Label Content

Uses

temporarily relieves cold symptoms:

  • cough due to minor throat & bronchial irritation
  • sneezing
  • runny nose
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients

(in each 15 mL)
Purpose

Chlorpheniramine maleate 2 mg

Antihistamine

Dextromethorphan HBr 15 mg

Cough suppressant

Directions
  • take only as directed
  • do not exceed 4 doses per 24 hrs.
  • only use the dose cup provided

adults & children 12 yrs & over

30 mL every 6 hrs.

children 6 to under 12 yrs

15 mL every 6 hrs.

children 4 to under 6 yrs

do not use unless directed by a doctor

children under 4 yrs

do not use

Do Not Use (Do not use)
  • 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.
  • to make a child sleepy
Other Information (Other information)
  • each 15 mL contains:potassium 5 mg, sodium 5 mg
  • sugar free
  • aspirin free
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Principal Display Panel 236 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label)

Compare to the active ingredients in Children’s Vicks Nyquil™ Cold & Cough*

NDC 51316-752-08

Nighttime

Childrens

Cold & Cough

Chlorpheniramine maleate 2 mg,

Dextromethorphan HBr 15 mg

  • Sneezing
  • Runny Nose
  • Cough

No Added Alcohol, Acetaminophen Free

Berry Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

DISTRIBUTED BY:

TAMPER EVIDENT:Do not use if printed shrink band is missing or broken.

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks ®Nyquil™ Cold & Cough.


Advanced Ingredient Data


Raw Label Data

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