TEXACLEAR KIDS ALLERGY- chlophedianol hcl pyrilamine maleate liquid

TexaClear Kids Allergy by

Drug Labeling and Warnings

TexaClear Kids Allergy 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® Kids Allergy Relief
(chlophedianol hcl, pyrilamine maleate) solution
GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL)

Chlophedianol HCl 12.5 mg
Pyrilamine Maleate 25 mg

Purpose

Cough Suppressant
Antihistamine

Uses

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

• itchy nose or throat
  
• sneezing
  
• itchy, watery eyes      
  
• runny nose
  
• 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

▪ 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
  
• avoid alcoholic drinks
  
• alcohol, sedatives, and tranquilizers may increase drowsiness
  
• 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 per 24 hours

▪ mL= milliliter

▪ use enclosed dose cup and keep with product

• adults and children 12 years of age and over: 60 mL (2 dose cups) every 6 to 8 hours
• children 6 to under 12 years of age: 30 mL (1 dose cup) every 6 to 8 hours
• children under 6 years: do not use.

Other information

▪ each 30 mL contains: Sodium 14 mg

▪ read all product information before using

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

Inactive ingredients

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

Questions or comments?

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

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

KEEP LEAFLET AFTER OPENING

Principal Display Panel

TexaClear® Kids Allergy + Cough
NDC: 58809-925-08
8 fl. oz. (237 mL)

Chlophedianol HCl – Cough Suppressant
Pyrilamine Maleate – Antihistamine

Tamper evident: do not use if foil seal under cap is broken on missing

• Gluten Free
  
• Dye Free
  
• Sugar Free
  
• Alcohol Free
  
• Acetaminophen Free

Ages 6+
Dose every 6 to 8 hours

• Sneezing
  
• Runny Nose
  
• Watery Eyes
  
• Itchy Nose & Throat
  
• Cough
  

Distributed by:
GM Pharmaceuticals, Inc. Arlington, TX 76015

INGREDIENTS AND APPEARANCE

TEXACLEAR KIDS ALLERGY 
chlophedianol hcl pyrilamine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-925
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 30 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	25 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 BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-925-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/15/2016

Labeler - GM Pharmaceuticals, INC (793000860)