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

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 57 mL)

Chlophedianol HCl 25 mg

Pyrilamine Maleate 50 mg

PURPOSE

Purpose

Cough suppressant

Antihistamine

INDICATIONS & USAGE

Uses

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

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

WARNINGS

Warnings

Do not exceed recommended dosage.

ASK DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

Stop use and ask a doctor if:

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days, 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

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

DOSAGE & ADMINISTRATION

Directions

• Do not exceed 4 (57mL) bottles in a 24-hour period

• Adults and children 12 years of age and over:

  Take 1 (57mL) bottle every 6 to 8 hours

• Children under 12 years of age:

  Do not use.

STORAGE AND HANDLING

Other information

• Each 57 mL bottle contains: Sodium 33 mg.
• tamper evident: Do not use if foil seal under cap is broken or missing.
• read all product information before using
• Store at 68° to 86°F (20° to 30°C).
• this package is child resistant

INACTIVE INGREDIENT

Inactive ingredients

Anhydrous Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

QUESTIONS

Questions? Comments?

Call 1-888-535-0305

SPL UNCLASSIFIED SECTION

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76015

PRODUCT LABELING

INGREDIENTS AND APPEARANCE

TEXACLEAR FAST ACTING ALLERGY RELIEF 
chlophedianol hydrochloride, pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-063
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 57 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	50 mg  in 57 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)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-063-60	57 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)