TEXACLEAR FAST ACTING ALLERGY RELIEF- chlophedianol hydrochloride, pyrilamine maleate liquid

Texaclear Fast Acting Allergy Relief by

Drug Labeling and Warnings

Texaclear Fast Acting Allergy Relief 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 FAST ACTING ALLERGY RELIEF

(Chlophedianol HCI & Pyrilamine Maleate), solution

GM Pharmaceuticals, Inc.

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GM Pharmaceuticals, Inc. TEXACLEAR FAST ACTING ALLERGY RELIEF

Drug Facts

Drug Facts

Active ingredients (in each 30 mL)

Chlophedianol HCl 25 mg 

Pyrilamine Maleate 50 mg

Purpose

Cough suppressant

Antihistamine

Uses

■ temporarily relieves these symptoms due to the common cold, hay fever or other upper respiratory allergies:

      ■ runny nose

      ■ sneezing

      ■ itching of the nose or throat

      ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Warnings

Ask a doctor before use if you have

■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if you are

■ taking sedative or tranquilizers

When using this product

■ do not use more than directed

■ marked drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness occurs

■ symptoms do not improve within 7 days, tend 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 professional 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 exceed 4 doses in any 24 hour period

■ use enclosed dose cup and keep with product

■ mL= milliliter

■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs

■ children under 12 years of age: do not use

Other information

■ each 30 mL contains: Sodium 17 mg

■ read all product information before using

■ store at room temperature 20-30°C (68-86°F)

Inactive ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 58809-360-08
TEXACLEAR
FAST ACTING
ALLERGY
RELIEF
8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

TEXACLEAR FAST ACTING ALLERGY RELIEF 
chlophedianol hydrochloride, pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-360
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  in 30 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-360-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/21/2014

Labeler - GM Pharmaceuticals, INC (793000860)