LEADER CHILDRENS MULTI SYMPTOM COLD - dextromethorphan hbr, guaifenesin, 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 Multi  Symptoms Cold  615

ACTIVE INGREDIENTS (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

PURPOSE

Cough suppressant

Expectorant

Nasal decongestant

USES

WARNINGS

.

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

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

       These could be signs of a serious illness.

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 years10 mL every 4 hours
children 4 years to under 6 years5 mL every 4 hours
children under 4 yearsdo not use

OTHER INFORMATION

INACTIVE INGREDIENTS

citric acid anhydrous, D&C red #33, dextrose, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

QUESTIONS OR COMMENTS?

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

PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0629-1

Children's Multi-Symptom Cold

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl


Cough Suppressant

Expectorant

Nasal Decongestant


Very Berry Flavor


Ages 4+ Years

Relieves:

Stuffy Nose

Chest Congestion

Controls Cough

Breaks Up Mucus

COMPARE TO

CHILDREN'S MUCINEX®

MULTI-SYMPTOM COLD

active ingredients*


4FL OZ (118 mL)

LDR_615_Carton

615_LDR_Labl

LEADER CHILDRENS MULTI SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0629
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DEXTROSE (UNII: IY9XDZ35W2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0629-11 in 1 CARTON03/15/2023
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 FINALpart34103/15/2023
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0629)

Revised: 3/2023
Document Id: 24a5872f-a700-44a8-b48d-e30d58abbf71
Set id: 169ff9cf-fcf5-46a6-b460-259421f2ec07
Version: 2
Effective Time: 20230330
 
CARDINAL HEALTH 110, LLC. DBA LEADER