FDA Label for Texaclear Fast Acting Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Texaclear Fast Acting Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 30 Ml)
Chlophedianol HCl 25 mg
Pyrilamine Maleate 50 mg
Purpose
Cough suppressant
Antihistamine
Uses
- temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
Do not exceed recommended dosage.
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.
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, tends 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 recommended dosage.
- do not take more than 4 doses in any 24-hour period
- dose as follows or as directed by a doctor
- use enclosed dosing cup
- do not use dosing cup with other products
- mL = milliliters
| adult and children 12 years and over | 30mL every 6-8 hours |
| children under 12 | do not use |
Other Information
- each 30 mL contains: Sodium 17 mg.
- tamper evident: Do not use if foil seal under cap is broken or missing.
- Read all product information before using
- store at 68° to 86°F (20° to 30°C).
- avoid excessive heat and humidity
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- 5p.m CST
Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015
Principal Display Panel
NDC 58809-360-08
TEXACLEAR
Fast Acting
ALLERGY
RELIEF
8 fl oz (237 mL)
* Please review the disclaimer below.