CLEAR CHOICE ALLERGY RELIEF- chlorpheniramine maleate tablet

Clear Choice Allergy Relief by

Drug Labeling and Warnings

Clear Choice Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Athlete's Needs Inc, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Chlorpheniramine Maleate 4 mg

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:

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

ASK DOCTOR/PHARMACIST

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

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

PREGNANCY OR BREAST FEEDING

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

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.

INACTIVE INGREDIENT

Inactive Ingredients: dicalcium phosphate, D&C yellow # 10 aluminum lake, lactose, magnesium stearate, microcrystalline
cellulose, stearic acid.

SPL UNCLASSIFIED SECTION

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

QUESTIONS

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

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

SPL UNCLASSIFIED SECTION

Manufactured for:

A.N.I. Toledo, OH 43623

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

INGREDIENTS AND APPEARANCE

CLEAR CHOICE ALLERGY RELIEF 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53185-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow (yellow)	Score	no score
Shape	ROUND (round)	Size	8mm
Flavor		Imprint Code	AZ246
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53185-001-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/23/2012

Labeler - Athlete's Needs Inc (619703945)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(53185-001)