TEXACLEAR- allergy relief tablet

TexaClear by

Drug Labeling and Warnings

TexaClear by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TEXACLEAR- ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET

GM Pharmaceuticals, Inc.

TexaClear Allergy Relief Tablet 30 count

Drug Facts

Active Ingredients (per tablet)

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

Purpose

Cough Suppressant

Antihistamine

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
  
• itchy, watery eyes
  
• itching of the nose or throat
  
• sneezing
  
• cough due to minor throat and bronchial irritation

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

• a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
  
• a cough that occurs with too much phlegm (mucus)
  
• glaucoma
  
• a breathing problem such as emphysema or chronic bronchitis
  
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
  
• marked drowsiness may occur
  
• avoid alcoholic drinks
  
• alcohol, sedatives, and tranquilizers may increase drowsiness 
  
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

• cough persists for more than 1 week, tends to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
  
• new symptoms occur

If pregnant or breast-feeding,

ask a health profession before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
  
• do not take more than 4 tablets in any 24-hour period.
  
• adults and children 12 years of age and over: Take 1 tablet every 6-8 hours
  
• children under the age of 12: do not use

Other Information

• avoid excess heat and humidity
  
• Store at room temperature 20-25 C(68-77 F)

Inactive Ingredients

Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch  

Questions or comments?

Call 1-888-535-0305 9 a.m.-5 p.m. CST

PRINCIPAL DISPLAY PANEL

NDC: 58809-186-30
TEXACLEAR
ALLERGY
RELIEF
30 Tablets

INGREDIENTS AND APPEARANCE

TEXACLEAR 
allergy relief tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-186
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	25 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	50 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-186-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/01/2015

Labeler - GM Pharmaceuticals, INC (793000860)