Sinus and Headache ACETAMINOPHEN AND PHENYLEPHRINE HCL CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages 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 crospovidone D&C yellow #10 aluminum lake FD&C blue #1 aluminum lake FD&C red #40 aluminum lake flavor magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone silicon dioxide sodium starch glycolate stearic acid sucralose talc titanium dioxide
Strengths
325 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Associated With Hay Fever Or Other Respiratory Allergies And The Common Cold Minor Aches And Pains Headache Nasal Congestion Sinus Congestion And Pressure Helps Decongest Sinus Openings And Passages Promotes Sinus Drainage Helps Clear Nasal Passages Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: green Imprint: 44;466

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0096295139907
UNII
362O9ITL9D 04JA59TNSJ
Packaging

Principal Display Panel LEADER™ NDC 70000-0568-1 Daytime | Non-Drowsy Sinus + Headache Acetaminophen , 325 mg Phenylephrine HCl, 5 mg Pain Reliever / Fever Reducer Nasal Decongestant Sinus Headache & Pressure Nasal Congestion COMPARE TO TYLENOL® SINUS + HEADACHE active ingredients* 100% Money Back Guarantee 24 CAPLETS Actual Size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® SINUS + HEADACHE. 50844 REV0721A46608 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ✔ 100% Money Back Guarantee Return to place of purchase. © 2024 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. CIN 5653191 REV. 09/24 Leader 44-466C Leader 44-466C

Package Descriptions
  • Principal Display Panel LEADER™ NDC 70000-0568-1 Daytime | Non-Drowsy Sinus + Headache Acetaminophen , 325 mg Phenylephrine HCl, 5 mg Pain Reliever / Fever Reducer Nasal Decongestant Sinus Headache & Pressure Nasal Congestion COMPARE TO TYLENOL® SINUS + HEADACHE active ingredients* 100% Money Back Guarantee 24 CAPLETS Actual Size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® SINUS + HEADACHE. 50844 REV0721A46608 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ✔ 100% Money Back Guarantee Return to place of purchase. © 2024 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. CIN 5653191 REV. 09/24 Leader 44-466C Leader 44-466C

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve 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: blisters rash skin reddening 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 high blood pressure thyroid disease liver disease diabetes heart disease 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


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →