Active Ingredients (In Each 30 Ml)
Chlophedianol HCl 25 mg
Pyrilamine Maleate 50 mg
Texaclear Fast Acting Allergy Relief Liquid
FDA Label NDC 58809-360
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 Fast Acting Allergy Relief (NDC 58809-360). 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 (in each 30 ml), purpose, uses, ask a doctor before use if you have, ask a doctor before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Antihistamine
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
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
Ask A Doctor Before Use If You Are
■ taking sedative 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 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)
Texaclear Pdp (Texaclear Fast Acting Allergy Relief 01)
Texaclear Drug Facts (Texaclear Fast Acting Allergy Relief 02)
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