LEADER COUGH TABS - guaifenesin tablet 
Cardinal Health

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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Drug Facts


Active ingredient (per tablet)

Guaifenesin  200mg

Purpose

Expectorant

Uses

Warnings

Ask doctor before use if you have

Stop use and ask doctor if

A persistent cough may be a sign of a serious condition.

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 immediately.

Directions

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

store at 15°-30°C (59°-86°F)

Inactive ingredients

FD C red No. 40 (Al-lake), magnesium stearate,  maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid.

image of bottle label

LEADER COUGH TABS 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-466
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorred (rose) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 151
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-466-721 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2005
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(37205-466) , repack(37205-466)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc187824339manufacture(37205-466)

Revised: 9/2012
Document Id: 788980a2-1879-4e9d-98a7-424667b2138a
Set id: 75a4491d-3252-46b1-b933-0ed2a13ec401
Version: 1
Effective Time: 20120913
 
Cardinal Health