SINUS AND HEADACHE ACETAMINOPHEN PHENYLEPHRINE HCL RITE AID CORPORATION FDA Approved Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache nasal congestion minor aches and pains sinus congestion and pressure helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
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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 Headache Nasal Congestion Minor Aches And Pains 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
0011822496681
UNII
362O9ITL9D 04JA59TNSJ
Packaging

Principal Display Panel Compare to the active ingredients in Tylenol ® SINUS + HEADACHE * NDC 11822-4669-8 SINUS & HEADACHE ACETAMINOPHEN 325 mg PHENYLEPHRINE HCl 5 mg PAIN RELIEVER / FEVER REDUCER NASAL DECONGESTANT DAYTIME • NON-DROWSY Relieves sinus headache & pressure, nasal congestion Pseudoephedrine Free ACTUAL SIZE 24 CAPLETS 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 ORG072146608 DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com SATISFACTION GUARANTEE: If you’re not satisfied, we’ll happily refund your money. Rite Aid 44-466C Rite Aid 44-466C

Package Descriptions
  • Principal Display Panel Compare to the active ingredients in Tylenol ® SINUS + HEADACHE * NDC 11822-4669-8 SINUS & HEADACHE ACETAMINOPHEN 325 mg PHENYLEPHRINE HCl 5 mg PAIN RELIEVER / FEVER REDUCER NASAL DECONGESTANT DAYTIME • NON-DROWSY Relieves sinus headache & pressure, nasal congestion Pseudoephedrine Free ACTUAL SIZE 24 CAPLETS 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 ORG072146608 DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com SATISFACTION GUARANTEE: If you’re not satisfied, we’ll happily refund your money. Rite Aid 44-466C Rite Aid 44-466C

Overview

Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache nasal congestion minor aches and pains 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: headache nasal congestion minor aches and pains 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 difficulty in urination due to enlargement of the prostate gland liver disease heart disease diabetes thyroid disease liver disease high blood pressure 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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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