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  5. Label Information: Childrens Cough And Cold

FDA Label for Childrens Cough And Cold

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. HOW SUPPLIED

Childrens Cough And Cold Product Label

The following document was submitted to the FDA by the labeler of this product Kingston Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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