Children's Cough & Cold Liquid

Children's Cough & Cold Liquid
SPL v2
SPL
SPL Set ID df3e9800-72c8-4f3a-a25c-89971684ed99
Route
ORAL
Published
Effective Date 2019-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-03-01

Description

Active Ingredient: Brompheniramine maleate 1 mg, Dextromethorphan HBr 5mg, Phenylephrine HCl 2.5 mg (in each 5 mL)


Medication Information

Warnings and Precautions

Warnings:

Indications and Usage

Cough & Cold

Dosage and Administration

Directions:

  • Use enclosed dosing cup.
  • Do not take more than 6 doses in any 24-hour period.
  • Adults and children 12 years and over: take 4 teaspoons or 20 mL every 4-6 hours.
  • Children 6 to under 12 years: take 2 teaspoons or 10 mL every 4-6 hours. ask a doctor
  • Children 4 to under 6 years: do not use unless directed by a doctor
  • Children under 4 years: do not use
Dosage Forms and Strengths

(packs: 4oz) Kingston NDC# 71027-047-04

Description

Active Ingredient: Brompheniramine maleate 1 mg, Dextromethorphan HBr 5mg, Phenylephrine HCl 2.5 mg (in each 5 mL)

Section 44425-7

Store between 20°C to 25°C (68° to 77° F)

Section 50565-1

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

Section 50567-7

When using this product

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • Nervousness, dizziness or sleeplessness occur
  • Symptoms do not get better within 7 days or are accompanied by fever
  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

A persistent cough may be a sign of a serious condition

Section 50569-3

Ask a doctor before use if you have

  • Glaucoma
  • Thyroid disease
  • High blood pressure
  • Heart disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • Taking sedatives or tranquilizers
Section 50570-1

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 sleep.
Section 51727-6

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Section 51945-4
Section 53414-9

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

Section 55105-1

Purpose: Children's Cough & Cold

Section 55106-9

Active Ingredient: Brompheniramine maleate 1 mg, Dextromethorphan HBr 5mg, Phenylephrine HCl 2.5 mg (in each 5 mL)


Structured Label Content

Indications and Usage (34067-9)

Cough & Cold

Dosage and Administration (34068-7)

Directions:

  • Use enclosed dosing cup.
  • Do not take more than 6 doses in any 24-hour period.
  • Adults and children 12 years and over: take 4 teaspoons or 20 mL every 4-6 hours.
  • Children 6 to under 12 years: take 2 teaspoons or 10 mL every 4-6 hours. ask a doctor
  • Children 4 to under 6 years: do not use unless directed by a doctor
  • Children under 4 years: do not use
Dosage Forms and Strengths (34069-5)

(packs: 4oz) Kingston NDC# 71027-047-04

Warnings and Precautions (34071-1)

Warnings:

Section 44425-7 (44425-7)

Store between 20°C to 25°C (68° to 77° F)

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

Section 50567-7 (50567-7)

When using this product

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • Nervousness, dizziness or sleeplessness occur
  • Symptoms do not get better within 7 days or are accompanied by fever
  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

A persistent cough may be a sign of a serious condition

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • Glaucoma
  • Thyroid disease
  • High blood pressure
  • Heart disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • Taking sedatives or tranquilizers
Section 50570-1 (50570-1)

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 sleep.
Section 51727-6 (51727-6)

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Section 51945-4 (51945-4)
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose: Children's Cough & Cold

Section 55106-9 (55106-9)

Active Ingredient: Brompheniramine maleate 1 mg, Dextromethorphan HBr 5mg, Phenylephrine HCl 2.5 mg (in each 5 mL)


Advanced Ingredient Data


Raw Label Data

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