Texaclear Kids Allergy

Texaclear Kids Allergy
SPL v9
SPL
SPL Set ID 3b8a686f-d8e8-56db-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2025-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlophedianol (12.5 mg) Pyrilamine (25 mg)
Inactive Ingredients
Propylene Glycol Glycerin Sodium Benzoate Sodium Citrate Anhydrous Citric Acid Sorbitol Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-15

Description

(in each 30 mL (2 TBSP)) Chlophedianol HCl 12.5 mg Pyrilamine Maleate 25 mg

Purpose

Cough Suppressant Antihistamine


Medication Information

Purpose

Cough Suppressant

Antihistamine

Description

(in each 30 mL (2 TBSP)) Chlophedianol HCl 12.5 mg Pyrilamine Maleate 25 mg

Uses

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

  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
  • runny nose
  • cough due to minor throat and bronchial irritation
Section 51945-4

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 76018

Section 53414-9

If pregnant or breast-feeding,as a health professional before use.

Warnings

Ask 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 the enlargment of the prostate gland
  • cough that occurs with too much phlegm(mucus)
  • a breathing problem such as emphysema or chronic bronchitis
Directions
  • Do not exceed 4 doses per 24-hours.
  • Use enclosed dose cup and keep with product.
  • mL = mililiter

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 of age: 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
Active Ingredients

(in each 30 mL (2 TBSP))

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 25 mg

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 76018

KEEP LEAFLET AFTER OPENING

When Using This Product
  • do not use more than directed
  • marked drowsiniess may occur
  • alcohol, secatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especiially 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 persisten headace. A persisten cough may be a sign of a serious condition.
  • new symptoms occur
Keep Out of Reach of Children.

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

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedative or tranquilizers

Structured Label Content

Uses

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

  • itchy nose or throat
  • sneezing
  • itchy, watery eyes
  • runny nose
  • cough due to minor throat and bronchial irritation
Section 51945-4 (51945-4)

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 76018

Section 53414-9 (53414-9)

If pregnant or breast-feeding,as a health professional before use.

Purpose

Cough Suppressant

Antihistamine

Warnings

Ask 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 the enlargment of the prostate gland
  • cough that occurs with too much phlegm(mucus)
  • a breathing problem such as emphysema or chronic bronchitis
Directions
  • Do not exceed 4 doses per 24-hours.
  • Use enclosed dose cup and keep with product.
  • mL = mililiter

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 of age: 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
Active Ingredients

(in each 30 mL (2 TBSP))

Chlophedianol HCl 12.5 mg

Pyrilamine Maleate 25 mg

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Distributed by:

GM Pharmaceuticals, Inc.

Arlington, TX 76018

KEEP LEAFLET AFTER OPENING

When Using This Product (When using this product)
  • do not use more than directed
  • marked drowsiniess may occur
  • alcohol, secatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especiially in children
Stop Use and Ask A Doctor If (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 persisten headace. A persisten cough may be a sign of a serious condition.
  • new symptoms occur
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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedative or tranquilizers

Advanced Ingredient Data


Raw Label Data

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