Family Dollar Children’s Cough & Cold

Family Dollar Children’s Cough & Cold
SPL v4
SPL
SPL Set ID 4c06b5cf-036d-4bbd-b055-a07bf2015beb
Route
ORAL
Published
Effective Date 2023-05-24
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 Glycerin Lactic Acid, Unspecified Form Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-08

Description

Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg

Purpose

Antihistamine Cough suppressant


Medication Information

Purpose

Antihistamine Cough suppressant

Description

Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg

Uses
  • 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
    • itchy, watery eyes
    • itching of the nose or throat
Purposes

Antihistamine

Cough suppressant

Directions
  • 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

Do Not Use
  • 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.
Other Information
  • each 10 mL contains: sodium 7 mg
  • store at room temperature. Do not refrigerate.
Inactive Ingredients

Anhydrous citric acid, FD&C red no. 40, Glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments?

1-866-467-2748

When Using This Product
  • 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

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

Prinipal Display of Packaging

Compare to the active ingredients in Children’s Robitussin ®Cough & Cold Long–Acting*

NDC 55319-754-04

CHILDREN’S

COUGH & COLD

Chlorpheniramine Maleate USP 2 mg (Antihistamine)

Dextromethorphan HBr, USP 15 mg (Cough Suppressant)

Long-Acting

Relieves:

  • Cough up to 8 hours
  • Runny nose
  • No Added alcohol
  • For Ages 6 & Over

Fruit Punch Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

IMPORTANT: Keep this carton for future reference on full labeling

Distributed by:

If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Active Ingredients (in Each 10 Ml)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged 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

taking sedatives or tranquilizers


Structured Label Content

Uses
  • 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
    • itchy, watery eyes
    • itching of the nose or throat
Purposes

Antihistamine

Cough suppressant

Directions
  • 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

Do Not Use (Do not use)
  • 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.
Other Information (Other information)
  • each 10 mL contains: sodium 7 mg
  • store at room temperature. Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, FD&C red no. 40, Glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-866-467-2748

When Using This Product (When using this product)
  • 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)

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

Prinipal Display of Packaging

Compare to the active ingredients in Children’s Robitussin ®Cough & Cold Long–Acting*

NDC 55319-754-04

CHILDREN’S

COUGH & COLD

Chlorpheniramine Maleate USP 2 mg (Antihistamine)

Dextromethorphan HBr, USP 15 mg (Cough Suppressant)

Long-Acting

Relieves:

  • Cough up to 8 hours
  • Runny nose
  • No Added alcohol
  • For Ages 6 & Over

Fruit Punch Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

IMPORTANT: Keep this carton for future reference on full labeling

Distributed by:

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

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

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • trouble urinating due to an enlarged 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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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