Severe Sinus Pain and Congestion ACETAMINOPHEN GUAIFENESIN PHENYLEPHRINE HCL CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 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 loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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 Guaifenesin 200 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients corn starch crospovidone flavor magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone silicon dioxide sodium starch glycolate stearic acid sucralose talc titanium dioxide
Strengths
325 mg 200 mg 5 mg
Quantities
44 count
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 Loosen Phlegm Mucus And Thin Bronchial Secretions To Make Coughs More Productive Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: white Imprint: 44;527

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 495W7451VQ 04JA59TNSJ
Packaging

Principal Display Panel NDC 51316-927-08 CVS ™ actual size Non-Drowsy SEVERE SINUS PAIN & CONGESTION Acetaminophen Pain Reliever, Fever Reducer Guaifenesin, Expectorant Phenylephrine HCl, Nasal Decongestant Compare to Tylenol ® Sinus Severe active ingredients* Relieves: Sinus headache, Sinus pressure, Chest congestion, Nasal congestion, Mucus 24 CAPLETS Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® Sinus Severe. 50844 ORG092252708 TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING cvs 44 527c cvs 44-527c

Package Descriptions
  • Principal Display Panel NDC 51316-927-08 CVS ™ actual size Non-Drowsy SEVERE SINUS PAIN & CONGESTION Acetaminophen Pain Reliever, Fever Reducer Guaifenesin, Expectorant Phenylephrine HCl, Nasal Decongestant Compare to Tylenol ® Sinus Severe active ingredients* Relieves: Sinus headache, Sinus pressure, Chest congestion, Nasal congestion, Mucus 24 CAPLETS Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® Sinus Severe. 50844 ORG092252708 TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING cvs 44 527c cvs 44-527c

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 loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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 loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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 cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 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, nasal congestion, or cough 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 cough comes back or occurs with rash or headache that lasts. 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 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 Expectorant 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, nasal congestion, or cough 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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of 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 each caplet contains: sodium 3 mg 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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