Leader 44-112

Leader 44-112

Drug Labeling and Warnings

Drug Details

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NASAL DECONGESTANT MAXIMUM STRENGTH- pseudoephedrine hcl 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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Leader 44-112

Active ingredient
(in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

Warnings

Do not use

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.   

Ask a doctor before use if you have

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with fever

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

adults and children
12 years and older

 take 2 tablets every 4 to 6 hours; do
 not take more than 8 tablets in
 24 hours 
children ages
6 to 12 years

 take 1 tablet every 4 to 6 hours; do
 not take more than 4 tablets in
 24 hours 
children under 6 years
 do not use this product in children
 under 6 years of age 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC: 70000-0135-2

LEADER™

Maximum Strength
Nasal Decongestant
Pseudoephedrine HCl, 30 mg | Nasal Decongestant

Non-Drowsy
Nasal & Sinus Congestion
Sinus Pressure

96 TABLETS
ACTUAL SIZE

COMPARE TO SUDAFED®
MAXIMUM STRENGTH CONGESTION

active ingredient*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed® Maximum Strength Congestion.

50844      ORG071211246

CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

All LEADER™ Brand Products Have A
100% Money Back Guarantee

Return to place of purchase if not satisfied.

©2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

Leader 44-112

Leader 44-112

NASAL DECONGESTANT  MAXIMUM STRENGTH
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0135-11 in 1 CARTON08/25/1981
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 70000-0135-24 in 1 CARTON08/25/1981
224 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/1981
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(70000-0135)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(70000-0135)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(70000-0135)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(70000-0135)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(70000-0135)

Revised: 12/2019
 
Cardinal Health


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