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TexaClear Kids Allergy

Medically reviewed on Apr 14, 2017

Dosage form: liquid
Ingredients: CHLOPHEDIANOL HYDROCHLORIDE 12.5mg in 30mL, PYRILAMINE MALEATE 25mg in 30mL
Labeler: GM Pharmaceuticals, INC
NDC Code: 58809-925

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

TEXACLEAR KIDS ALLERGY

TexaClear® Kids Allergy Relief

(chlophedianol hcl, pyrilamine maleate) solution

GM Pharmaceuticals, Inc.

Drug Facts

Active ingredients (in each 30 mL (2 TBSP))

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 (allergic rhinitis) or other upper

respiratory allergies:

▪ cough due to minor throat and bronchial irritation

▪ runny nose

▪ sneezing

▪ itchy, watery eyes

▪ itching of the nose or throat

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

▪ a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

▪ taking sedatives 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 per 24 hrs

▪ use enclosed dose cup and keep with product

▪ TBSP= tablespoon, mL= milliliter

adults & children 12 yrs & over:60 mL (4 TBSP) every 6 to 8 hrs
children 6 to under 12 yrs:30 mL (2 TBSP) every 6 to 8 hrs
children under 6 yrs:do not use.

Other information

▪ each 30 mL (2 TBSP) contains: Sodium 23 mg

▪ tamper evident: Do not use if foil seal under cap is broken or missing.

▪ read all product information before using

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

▪ avoid excessive heat and humidity

Inactive ingredients

bitter mask, citric acid, glycerin, polyethylene 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

R041417

Principal Display Panel

TexaClear® Kids Allergy Relief

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
  • Decongestant Free


Ages 6+

Relieves:

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

Distributed by:

GM Pharmaceuticals, Inc. Arlington, TX 76015

TEXACLEAR KIDS ALLERGY 
chlophedianol hcl pyrilamine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-925
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 30 mL
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE25 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOLS 
GLYCERIN 
SODIUM BENZOATE 
SODIUM CITRATE 
ANHYDROUS CITRIC ACID 
SORBITOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:58809-925-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/15/2016
Labeler - GM Pharmaceuticals, INC (793000860)

 
GM Pharmaceuticals, INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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