Sinus Pressure and Pain Maximum Strength ACETAMINOPHEN PHENYLEPHRINE HCL CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium crospovidone FD&C yellow #6 aluminum lake magnesium stearate microcrystalline cellulose povidone silicon dioxide stearic acid
Strengths
325 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Associated With Hay Fever Or Other Upper Respiratory Allergies And The Common Cold Minor Aches And Pains Nasal Congestion Headache Sinus Congestion And Pressure Promotes Sinus Drainage Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: orange Imprint: 44;502

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 04JA59TNSJ
Packaging

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 Cardinal Health™ 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

Package Descriptions
  • 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 Cardinal Health™ 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

Overview

Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever

Dosage & Administration

Directions do not use more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash 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.
Purpose

Purpose Pain reliever/fever reducer Nasal decongestant

Do Not Use

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

When Using

When using this product do not exceed recommended dosage.

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Questions

Questions or comments? 1-800-426-9391


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