SINUS PRESSURE AND PAIN MAXIMUM STRENGTH- acetaminophen, phenylephrine hcl tablet 
Cardinal Health 110, LLC. DBA Leader

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Leader 44-502

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • liver disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

LEADER

NDC 70000-0161-1

Maximum Strength

Sinus Pressure + Pain  

Acetaminophen | Pain Reliever / Fever Reducer
Phenylephrine HCl | Nasal Decongestant

Non-Drowsy

Relieves:
Sinus Headache, Sinus Pressure,
Nasal Congestion

24 CAPLETS

 Actual Size

COMPARE TO
SUDAFED PE® SINUS
PRESSURE + PAIN
active ingredients*

100% Money Back Guarantee 

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

CIN 5294335    REV. 3/21

*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Sudafed PE® Sinus
Pressure + Pain         50844        REV0820B50208

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

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

©2021 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
ESSENTIAL TO CARE, LEADER, and the Leader LOGO
are trademarks or registered trademarks of
Cardinal Health. All other marks are property
of their respective owners.

100% Money Back Guarantee
Return to place of purchase if not satisfied.

Leader 44-502

Leader 44-502

SINUS PRESSURE AND PAIN  MAXIMUM STRENGTH
acetaminophen, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize18mm
FlavorImprint Code 44;502
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0161-12 in 1 CARTON06/23/2005
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/23/2005
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(70000-0161) , pack(70000-0161)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(70000-0161)

Revised: 4/2024
Document Id: 901eacd0-e151-4de3-9990-468e7bcd8cb0
Set id: 80d25e23-b108-4eb1-88c7-73fe9da8f942
Version: 11
Effective Time: 20240418
 
Cardinal Health 110, LLC. DBA Leader