CHILDRENS COLD AND COUGH - brompheniramine maleate, dextromethorphan, phenylephrine hcl liquid 
CARDINAL HEALTH 110, LLC. DBA LEADER

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Childrens Cold and Cough 577

ACTIVE INGRADIENTS (in each 10 mL)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10  mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Antihistamine

Cough Suppressant

Nasal decongestant

USES


WARNINGS

.

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


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 (1-800-222-1222) right away.

DIRECTIONS


                     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



OTHER INFORMATION

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

QUESTIONS OR COMMENTS?

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

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

    



CHILDRENS COLD AND COUGH 
brompheniramine maleate, dextromethorphan, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0631
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0631-11 in 1 CARTON03/30/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/30/2023
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0631)

Revised: 3/2023
Document Id: 24c1f90c-7b2e-4e86-a2f6-d23f74e0708b
Set id: 24c1f90c-7b2e-4e86-a2f6-d23f74e0708b
Version: 1
Effective Time: 20230330
 
CARDINAL HEALTH 110, LLC. DBA LEADER