Leader Childrens Cold And Cough Solution
FDA Label NDC 70000-0715

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Childrens Cold And Cough (NDC 70000-0715). 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 active ingredients (in each 10 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 10 Ml)

Brompheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Purposes

Antihistamine

Cough suppressant

Uses

  • temporarily relieves:
  • cough
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
  • temporarily alleviates the intensity of coughing

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 sleepy

Ask A Doctor Before Use If You Have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 (1-800-222-1222).

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • mL = milliliter

    • age

    dose

    adults and children 12 years over

    20 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    children under 6 years

    do not use

Other Information

  • each 10 mL contains: sodium 4 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

LEADER™

Children’s

Cold & Cough

Brompheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Grape Flavor

For Ages 6 yrs and Over

Relieves: Runny Nose

Itchy, Watery Eyes

Coughing

Sneezing

COMPARE TO CHILDREN’S DIMETAPP® COLD & COUGH active ingredients

Alcohol-Free

100% Money Back Guarantee

4 FL OZ (118 mL)

SAFE AND EFFECTIVE RELIEF WITHOUT PHENYLEPHRINE

Children's Cold & Cough Carton (26k26e9c1)

Children's Cold & Cough Carton (26k26e9c1)

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