Texaclear Fast Acting Allergy Relief Tablet

Texaclear Fast Acting Allergy Relief Tablet
SPL v8
SPL
SPL Set ID 2a06e00a-0887-4386-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2020-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlophedianol (25 mg) Pyrilamine (50 mg)
Inactive Ingredients
Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AC Shape: oval Color: white Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-01

Description

TEXACLEAR-ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET GM Pharmaceuticals , Inc. TexaClear Allergy Relief Tablet 30 count Drug Facts

Purpose

Cough Suppressant Antihistamine


Medication Information

Purpose

Cough Suppressant

Antihistamine

Description

TEXACLEAR-ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET GM Pharmaceuticals , Inc. TexaClear Allergy Relief Tablet 30 count Drug Facts

Uses
  • temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
    • sneezing
    • cough due to minor throat and bronchial irritation
Section 42229-5

TEXACLEAR-ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET

GM Pharmaceuticals , Inc.

TexaClear Allergy Relief Tablet 30 count

Drug Facts

Directions
  • do not exceed 4 tablets per 24-hour period.
adults and children 12 years and older: take 1 tablet every 6 to 8 hours.
children under 12 years: do not use.
Other Information
  • tamper evident: do not use if foil seal under the cap is broken or missing
  • This package is child-resistant.
  • read all information before using
  • store at room temperature 20-30°C (68-86°F)
  • avoid excess heat and humidity
Inactive Ingredients

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, stearic acid

Questions Or Comments?

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

Principal Display Panel

NDC 58809-186-30

TEXACLEAR

ALLERGY

RELIEF

30 Tablets

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 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.

Active Ingredients (per Tablet)

Chlophedianol HCl ...... 25 mg

Pyrilamine Maleate ...... 50 mg

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 A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses
  • temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
    • sneezing
    • cough due to minor throat and bronchial irritation
Section 42229-5 (42229-5)

TEXACLEAR-ALLERGY RELIEF (Chlophedianol HCl, Pyrilamine Maleate) TABLET

GM Pharmaceuticals , Inc.

TexaClear Allergy Relief Tablet 30 count

Drug Facts

Purpose

Cough Suppressant

Antihistamine

Directions
  • do not exceed 4 tablets per 24-hour period.
adults and children 12 years and older: take 1 tablet every 6 to 8 hours.
children under 12 years: do not use.
Other Information
  • tamper evident: do not use if foil seal under the cap is broken or missing
  • This package is child-resistant.
  • read all information before using
  • store at room temperature 20-30°C (68-86°F)
  • avoid excess heat and humidity
Inactive Ingredients

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 58809-186-30

TEXACLEAR

ALLERGY

RELIEF

30 Tablets

When Using This Product (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 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 persistent headache. A persistent cough may be a sign of a serious condition
  • new symptoms occur
If Pregnant 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.

Active Ingredients (per Tablet) (Active Ingredients (per tablet))

Chlophedianol HCl ...... 25 mg

Pyrilamine Maleate ...... 50 mg

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

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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