CHILDRENS MUCUS AND COUGH RELIEF- dextromethorphan hbr, guaifenesin liquid 
CARDINAL HEALTH 110, LLC. DBA LEADER

----------

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 DrugM01203/22/2023
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0630)

Revised: 12/2024
Document Id: dd0e9919-5bb8-4eb8-936b-62714ecd0964
Set id: 125eeb3d-0ee2-45bb-81c0-4ca699979886
Version: 2
Effective Time: 20241216
 
CARDINAL HEALTH 110, LLC. DBA LEADER