Childrens Cough And Cold
FDA Label NDC 71027-047

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingston Pharma Llc for the product Childrens Cough And Cold (NDC 71027-047). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

Otc - Purpose

Purpose: Children's Cough & Cold

Indications & Usage

Cough & Cold

Warnings

Warnings:

Otc - 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 sleep.

Otc - Ask Doctor

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

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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.

Otc - Pregnancy Or Breast Feeding

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

Dosage & 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

Storage And Handling

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

Inactive Ingredient

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

How Supplied

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

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