Defensol D Blister Pack ACETAMINOPHEN DIPHENHYDRAMINE HCL PHENYLEPHRINE HCI MENPER DISTRIBUTORS, INC. FDA Approved Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCI 5 mg
Inactive Ingredients
Inactive ingredients corn starch croscarmellose sodium crospovidone FD&C blue#1 aluminum lake FO&C blue#2 aluminum lake iron oxide yellow magnesium stearate methacrylic acid and ethyl acrylate copolymer microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone s I con dioxide sodium bicarbonate stearic acid talc titanium oxide.
Strengths
325 mg 12.5 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Associated With Cold Or Flu Headache Nasal Congestion Sore Throat Fever Minor Aches And Pains Temporarily Relieves Minor Aches Pains And Headache As Well As Those Symptoms Of Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Nasal Congestion Itching Of The Nose Or Throat Itchy Watery Eyes Temporarily Relieves Minor Aches Headache And Nasal Congestion As Well As Sinus Congestion And Pressure And Reduces Swelling Of Nasal Passages
Pill Appearance
Shape: rectangle Color: blue

Identifiers & Packaging

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

Pack

Package Descriptions
  • Pack

Overview

Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

Indications & Usage

Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

Dosage & Administration

Directions : do not take more than 12 tablets in a 24 hour period. do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. This adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 tablets every 4 hours children under 12 years do not use

Warnings & Precautions
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Severe throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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.
Purpose

Purpose Pain Reliever Antihistamine/ Cough Suppresant 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 MADI drug. If you do not know if your prescription drug contains MADI, ask a doctor or pharmacist befaretakingthisprocluct. ■ if you have ever had an allergic reaction to this product or any of its ingredients ■ to sedate a child or to make a child sleepy ■ with any other product containing diphenhydramine, even one used on skin.

When Using

When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur in children

Stop Use & Ask a Doctor

Stop use and ask a doctor if you get nervous, dizzy, or sleepless 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.

Questions

Questions? Menper Distributors, Inc. 1-800-560-5223; M-F 9 AM - 4 PM Eastern


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