Severe Allergy And Sinus Headache Maximum Strength ACETAMINOPHEN DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL CVS PHARMACY FDA Approved Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion sneezing runny nose sinus congestion and pressure itchy, watery eyes itching of the nose or throat minor aches and pains
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium crospovidone FD&C blue #1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol povidone silicon dioxide stearic acid titanium dioxide triacetin
Strengths
325 mg 25 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Of Hay Fever Or Other Upper Respiratory Allergies Headache Nasal Congestion Sneezing Runny Nose Sinus Congestion And Pressure Itchy Watery Eyes Itching Of The Nose Or Throat Minor Aches And Pains
Pill Appearance
Shape: oval Color: blue Imprint: 44;543

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D TC2D6JAD40 04JA59TNSJ
Packaging

Principal Display Panel ♥ CVS Health ™ Caplets MAXIMUM STRENGTH Severe Allergy & Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HCl PHENYLEPHRINE HCl Pain reliever, Antihistamine & Nasal decongestant For Allergy Plus Sinus Pain & Pressure Relief of: Sneezing, Runny nose, Sinus headache, Sinus congestion, Sinus pain & pressure, Itchy, watery eyes 20 CAPLETS Capsule-Shaped Tablets 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: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-18615 CVS® Quality Money Back Guarantee 50844 REV0918D54309 CVS 44-543 CVS 44-543

Package Descriptions
  • Principal Display Panel ♥ CVS Health ™ Caplets MAXIMUM STRENGTH Severe Allergy & Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HCl PHENYLEPHRINE HCl Pain reliever, Antihistamine & Nasal decongestant For Allergy Plus Sinus Pain & Pressure Relief of: Sneezing, Runny nose, Sinus headache, Sinus congestion, Sinus pain & pressure, Itchy, watery eyes 20 CAPLETS Capsule-Shaped Tablets 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: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-18615 CVS® Quality Money Back Guarantee 50844 REV0918D54309 CVS 44-543 CVS 44-543

Overview

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion sneezing runny nose sinus congestion and pressure itchy, watery eyes itching of the nose or throat minor aches and pains

Indications & Usage

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion sneezing runny nose sinus congestion and pressure itchy, watery eyes itching of the nose or throat minor aches and pains

Dosage & Administration

Directions do not take 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. with any other product containing diphenhydramine, even one used on skin 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 glaucoma heart disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages 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 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 Antihistamine 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. with any other product containing diphenhydramine, even one used on skin 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 excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages

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

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 see end flap for expiration date and lot number 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)

Questions

Questions or comments? 1-800-426-9391


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