Children's

Children's
SPL v1
SPL
SPL Set ID 03401433-923e-4577-ba58-9087515c8053
Route
ORAL
Published
Effective Date 2009-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (1 mg) Dextromethorphan (7.5 mg)
Inactive Ingredients
Fruit Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: red Color: pink
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-11-25

Description

COUGH & COLD LONG-ACTING Drug Facts


Medication Information

Description

COUGH & COLD LONG-ACTING Drug Facts

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
Section 42229-5

COUGH & COLD LONG-ACTING

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.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 53414-9

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

Section 55105-1
Active ingredients

(in each 5 mL tsp)
Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant
Directions
  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
age dose
under 6 years do not use
6 to under 12 years 1-2 tsp. (5-10 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.
Questions?

877-434-2036

Other Information
  • each teaspoon contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

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
Principal Display Panel 118 Ml Carton

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

Cough & Cold

Long-Acting

ACCURATE DOSING

BY WEIGHT

Chlorpheniramine Maleate

(Antihistamine)

Dextromethorphan HBr

(Cough Suppressant)

RELIEVES

Cough: Up to 8 Hours

Runny Nose

For Ages 6 to under 12

Compares to Children's

Robitussin® Cough &

Cold Long-Acting.

FRUIT

PUNCH

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-151-04

Ask A Doctor Before Use If the Child Has
  • 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

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
Section 42229-5 (42229-5)

COUGH & COLD LONG-ACTING

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.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking 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 5 mL tsp)
Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant
Directions
  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
age dose
under 6 years do not use
6 to under 12 years 1-2 tsp. (5-10 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.
Questions?

877-434-2036

Other Information (Other information)
  • each teaspoon contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

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
Principal Display Panel 118 Ml Carton (PRINCIPAL DISPLAY PANEL - 118 mL Carton)

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

Cough & Cold

Long-Acting

ACCURATE DOSING

BY WEIGHT

Chlorpheniramine Maleate

(Antihistamine)

Dextromethorphan HBr

(Cough Suppressant)

RELIEVES

Cough: Up to 8 Hours

Runny Nose

For Ages 6 to under 12

Compares to Children's

Robitussin® Cough &

Cold Long-Acting.

FRUIT

PUNCH

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-151-04

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • 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

Advanced Ingredient Data


Raw Label Data

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