Texaclear Kids Allergy Liquid
FDA Label NDC 58809-925

14 label sections · Submitted to the FDA by Gm Pharmaceuticals, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc. for the product Texaclear Kids Allergy (NDC 58809-925). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label.principal Display Panel

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:

itchy nose or throat
sneezing
itchy, watery eyes
runny nose
cough due to minor throat and bronchial irritation

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedative or tranquilizers

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,as 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.
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.