Childrens Cold and Cough BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN PHENYLEPHRINE HCL CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved USES temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): sneezing Itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose
FunFoxMeds box
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGRADIENTS (in each 10 mL) Brompheniramine maleate USP 2 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg
Inactive Ingredients
INACTIVE INGREDIENTS anhydrous citric acid artificial flavor FD&C blue #1 FD&C Red #40 flavor glycerin propylene glycol propyl gallate purified water sodium benzoate sodium citrate sorbitol sucralose
Strengths
10 ml 2 mg 10 mg 5 mg
Quantities
118 ml
Treats Conditions
Uses Temporarily Relieves Cough Due To Minor Bronchial Irritation As May Occur With A Cold And Nasal Congestion Due To The Common Cold Hay Fever Or Other Upper Respiratory Allergies Temporarily Relieves These Symptoms Due To Hay Fever Allergic Rhinitis Sneezing Itching Of The Nose Or Throat Runny Nose Itchy Watery Eyes Temporarily Restores Freer Breathing Through The Nose
Pill Appearance
Color: purple

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
IXA7C9ZN03 9D2RTI9KYH 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL LEADER NDC 70000-0631-1 Children's Cold & Cough Liquid Brompheniramine Maleate Dextromethorphan Hydrobromide Phenylephrine Hydrochloride Antihistamine Cough Suppressant Nasal Decongestant Grape Flavor Relieves : Stuffy Nose, Runny Nose, Sneezing, Cough Alcohol-Free COMPARE TO CHILDREN'S DIMETAPP ® COLD & COUGH active ingredients* 4 FL OZ (118 mL) LDR_577_Crt ldr_577_lbl

Package Descriptions
  • PRINCIPAL DISPLAY PANEL LEADER NDC 70000-0631-1 Children's Cold & Cough Liquid Brompheniramine Maleate Dextromethorphan Hydrobromide Phenylephrine Hydrochloride Antihistamine Cough Suppressant Nasal Decongestant Grape Flavor Relieves : Stuffy Nose, Runny Nose, Sneezing, Cough Alcohol-Free COMPARE TO CHILDREN'S DIMETAPP ® COLD & COUGH active ingredients* 4 FL OZ (118 mL) LDR_577_Crt ldr_577_lbl

Overview

USES temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): sneezing Itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose

Indications & Usage

USES temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): sneezing Itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose

Dosage & Administration

DIRECTIONS do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not exceed recommended dosage mL = milliliter Age Dose adults & 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

Warnings & Precautions
WARNINGS .
Purpose

PURPOSES Antihistamine Cough Suppressant Nasal decongestant

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, or psychiatric, 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.

When Using

WHEN USING THIS PRODUCT do not take more than directed may cause drowsiness alcohol, sedatives, and tranquillizers may increase drowsiness avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

Stop Use & Ask a Doctor

STOP USE AND ASK A DOCTOR IF nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever 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.

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Questions

QUESTIONS OR COMMENTS? call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est


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