Severe Cold Relief PE Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine Starch, Corn Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Polyvinyl Alcohol Povidone Silicon Dioxide Stearic Acid Talc Titanium Dioxide 44;526 Product Label Uses temporarily relieves these symptoms of the common cold: runny nose sneezing headache minor aches and pains nasal congestion cough sore throat temporarily reduces fever

Severe Cold Relief PE Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl Acetaminophen Acetaminophen Diphenhydramine Hydrochloride Diphenhydramine Phenylephrine Hydrochloride Phenylephrine Starch, Corn Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Polyvinyl Alcohol Povidone Silicon Dioxide Stearic Acid Talc Titanium Dioxide 44;526 Product Label

Mfr: OTC
FunFoxMeds box

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone silica gel stearic acid talc titanium dioxide
Strengths
325 mg 12.5 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Of The Common Cold Runny Nose Sneezing Headache Minor Aches And Pains Nasal Congestion Cough Sore Throat Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: 44;526

Identifiers & Packaging

Container Type BOX
Packaging

PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. CVS® pharmacy Compare to the active ingredients in Sudafed PE® Severe Cold* See New Warnings Information SEVERE COLD RELIEF PE MULTI-SYMPTOM ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl PAIN RELIEVER/FEVER REDUCER, ANTIHISTAMINE COUGH SUPPRESSANT, NASAL DECONGESTANT ● Nasal & Sinus Congestion ● Fever & Body Aches ● Cough & Sore Throat Does not contain Pseudoephedrine 24 COATED CAPLETS TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV1209B52608 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2010 CVS/pharmacy www.cvs.com 1-800-shop-CVS

Package Descriptions
  • PRODUCT PACKAGING The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. CVS® pharmacy Compare to the active ingredients in Sudafed PE® Severe Cold* See New Warnings Information SEVERE COLD RELIEF PE MULTI-SYMPTOM ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl PAIN RELIEVER/FEVER REDUCER, ANTIHISTAMINE COUGH SUPPRESSANT, NASAL DECONGESTANT ● Nasal & Sinus Congestion ● Fever & Body Aches ● Cough & Sore Throat Does not contain Pseudoephedrine 24 COATED CAPLETS TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV1209B52608 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2010 CVS/pharmacy www.cvs.com 1-800-shop-CVS

Overview

Uses temporarily relieves these symptoms of the common cold: runny nose sneezing headache minor aches and pains nasal congestion cough sore throat temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms of the common cold: runny nose sneezing headache minor aches and pains nasal congestion cough sore throat temporarily reduces fever

Dosage & Administration

Directions do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children 6 to under 12 years of age take one caplet every 4 hours do not take more than 5 caplets in 24 hours children under 6 years of age do not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 caplets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taking with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, condult a doctor promptly.
Purpose

Purpose Pain reliever/fever reducer Antihistamine/cough suppressant 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 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 avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Centrer right away. Quick 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 store at controlled room temperature 15°-30°C (59°-86°F)

Questions

Questions or comments? 1-800-426-9391


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