Sinus Congestion and Pain Daytime ACETAMINOPHEN AND PHENYLEPHRINE HCL UNITED NATURAL FOODS, INC. DBA UNFI 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
0041163438316
UNII
362O9ITL9D 04JA59TNSJ
Packaging

Principal Display Panel NDC 41163-664-08 EQUAL INE® compare to Tylenol® SINUS + HEADACHE active ingredients* daytime sinus congestion & pain acetaminophen (pain reliever/fever reducer) phenylephrine HCl (nasal decongestant) non-drowsy relieves: • sinus headache & pressure • nasal congestion PSEUDOEPHEDRINE FREE 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 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS + HEADACHE. 50844 REV0721H46608 Equaline 44-466C Equaline 44-466C

Package Descriptions
  • Principal Display Panel NDC 41163-664-08 EQUAL INE® compare to Tylenol® SINUS + HEADACHE active ingredients* daytime sinus congestion & pain acetaminophen (pain reliever/fever reducer) phenylephrine HCl (nasal decongestant) non-drowsy relieves: • sinus headache & pressure • nasal congestion PSEUDOEPHEDRINE FREE 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 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS + HEADACHE. 50844 REV0721H46608 Equaline 44-466C Equaline 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 liver disease difficulty in urination due to enlargement of the prostate gland heart disease diabetes thyroid 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Questions

Questions or comments? 1-855-423-2630


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