Clear Choice Allergy Relief
FDA Label NDC 53185-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Athlete's Needs Inc for the product Clear Choice Allergy Relief (NDC 53185-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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