Texaclear Fast Acting Allergy Relief

Texaclear Fast Acting Allergy Relief
SPL v12
SPL
SPL Set ID 17a2f643-fa98-21ee-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2023-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlophedianol (25 mg) Pyrilamine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-21

Description

(Chlophedianol HCI & Pyrilamine Maleate), solution GM Pharmaceuticals, Inc. Drug Facts

Purpose

Cough suppressant Antihistamine


Medication Information

Purpose

Cough suppressant

Antihistamine

Description

(Chlophedianol HCI & Pyrilamine Maleate), solution GM Pharmaceuticals, Inc. Drug Facts

Uses

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

      ■ runny nose

      ■ sneezing

      ■ itching of the nose or throat

      ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Section 42229-5

(Chlophedianol HCI & Pyrilamine Maleate), solution

GM Pharmaceuticals, Inc.

Drug Facts

Directions

■ do not exceed 4 doses in any 24 hour period

■ use enclosed dose cup and keep with product

■ mL= milliliter

■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs

■ children under 12 years of age: do not use

Other Information

■ each 30 mL contains: Sodium 17 mg

■ read all product information before using

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

Inactive Ingredients

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

Questions Or Comments?

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

Principal Display Panel

NDC 58809-360-08

TEXACLEAR

FAST ACTING

ALLERGY

RELIEF

8 fl oz (237 mL)

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.

Active Ingredients (in Each 30 Ml)

Chlophedianol HCl 25 mg 

Pyrilamine Maleate 50 mg

Ask A Doctor Before Use If You Are

■ taking sedative or tranquilizers

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

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis


Structured Label Content

Uses

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

      ■ runny nose

      ■ sneezing

      ■ itching of the nose or throat

      ■ itchy, watery eyes

■ cough due to minor throat and bronchial irritation

Section 42229-5 (42229-5)

(Chlophedianol HCI & Pyrilamine Maleate), solution

GM Pharmaceuticals, Inc.

Drug Facts

Purpose

Cough suppressant

Antihistamine

Directions

■ do not exceed 4 doses in any 24 hour period

■ use enclosed dose cup and keep with product

■ mL= milliliter

■ adults and children 12 yrs and over: 30 mL every 6 to 8 hrs

■ children under 12 years of age: do not use

Other Information (Other information)

■ each 30 mL contains: Sodium 17 mg

■ read all product information before using

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

Inactive Ingredients (Inactive ingredients)

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

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 58809-360-08

TEXACLEAR

FAST ACTING

ALLERGY

RELIEF

8 fl oz (237 mL)

When Using This Product (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 (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 (in Each 30 Ml) (Active ingredients (in each 30 mL))

Chlophedianol HCl 25 mg 

Pyrilamine Maleate 50 mg

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

■ taking sedative or tranquilizers

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

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ a cough that occurs with too much phlegm (mucus)

■ a breathing problem such as emphysema or chronic bronchitis


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)