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  5. Label Information: Defensol D Blister Pack

FDA Label for Defensol D Blister Pack

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSAGE
    12. DOSAGE & ADMINISTRATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Defensol D Blister Pack Product Label

The following document was submitted to the FDA by the labeler of this product Menper Distributors, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients (in each tablet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCI 5 mg


Otc - Purpose



Purpose

Pain Reliever

Antihistamine/ Cough Suppresant

Nasal Decongestant


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


Warnings



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.


Otc - 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.


Otc - Ask Doctor



Ask doctor before use if you have

  • liver desease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • taking the blood thinning drug warfarin
  • taking any other oral nasal decongestant or stimulant
  • taking any other pain relieve/fever reducer
  • taking sedatives or tranquilizers

Otc - 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

Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding,ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



Overdose warning: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.


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


Inactive Ingredient



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.


Otc - Questions



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


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