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  5. Label Information: Clear Choice Allergy Relief

FDA Label for Clear Choice Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clear Choice Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Athlete's Needs 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.

Other



Drug Facts

This product is not manufactured or distributed by Schering-Plough, owner of the registered trademark Chlor-Trimeton(R).

Manufactured for:

A.N.I. Toledo, OH 43623


Otc - Active Ingredient



Active ingredient (in each tablet)

Chlorpheniramine Maleate 4 mg


Otc - Purpose



Purpose

Antihistamine


Indications & Usage



USES: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies, sneezing, runny nose, itchy, watery eyes, itchy nose or throat


Warnings



Warnings:


Otc - Ask Doctor



Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis

glaucoma or

trouble urinating due to enlargement of the prostate gland


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


Otc - When Using



When using this product

marked drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur especially in children


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. In case of accidental overdose, contact a doctor or Poison Control Center immediately


Dosage & Administration



Directions

  • take every 4 to 6 hours,
  • do not take more than 6 does in 24 hours
  • Adults and children 12 years and over: 1 tablet
  • Children 6 to under 12 years: 1/2 tablet
  • Children under 6 years: consult a doctor

Storage And Handling



Other Information

store at room temperature in a dry place

do not use if imprinted safety seal under cap is broken or missing.


Otc - Questions



To Report Adverse Drug Events, call 1-888-952-0050

Questions? Contact A.N.I. Toledo, Ohio


Package Label.Principal Display Panel



Clear Choice

ALLERGY RELIEF

Antihistamine Chlorpheniramine Maleate

4 Hour

RELIEVES: SNEEZING, WATERY EYES, ITCHY THROAT, RUNNY NOSE

Compare to Chlor-Trimeton(R)

24 Tablets

4 mg Each

allergy relief label - arlabel

allergy relief label - arlabel


* Please review the disclaimer below.