CHILDRENS MUCUS AND COUGH RELIEF - dextromethorphan hbr, guaifenesin 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 Mucus and Cough 

ACTIVE INGREDIENTS (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

PURPOSE

Cough suppressant
Expectorant

USES

WARNING

.

DO NOT USE

in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


ASK A DOCTOR BEFORE USE IF THE CHILD HAS


STOP USE AND ASK A DOCTOR IF


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
 children 6 years to under 12 years 5 mL-10 mL
 every 4 hours
 children 4 years to under 6 years 2.5 mL - 5 mL
 every 4 hours
 children under 4 years do not use




OTHER INFORMATION

INACTIVE INGREDIENTS

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

QUESTIONS COMMENTS?

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

PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0630-1 

Children's Mucus & Cough Relief

Dextromethorphan HBr, 5mg

Guaifenesin 100 mg

cough Suppressant 

Expectorant

Cherry Flavor 

Ages 4+ Years

Controls Cough

Relieves Chest Congestion

Thins and Loosen Mucus

COMPARE TO CHILDREN'S MUCINEX® COUGH

active ingredients*
4 FL OZ (118mL)

LDR_552_CARTON
















552_LDR_LABLE

CHILDRENS MUCUS AND COUGH RELIEF 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0630
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0630-11 in 1 CARTON03/22/2023
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 FINALpart34103/22/2023
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0630)

Revised: 3/2023
Document Id: 125eeb3d-0ee2-45bb-81c0-4ca699979886
Set id: 125eeb3d-0ee2-45bb-81c0-4ca699979886
Version: 1
Effective Time: 20230322
 
CARDINAL HEALTH 110, LLC. DBA LEADER