FDA Label for Texaclear Fast Acting Allergy Relief
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRODUCT LABELING
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.
Other
Drug Facts
Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015
Otc - Active Ingredient
Active ingredients
(in each 57 mL)
Chlophedianol HCl 25 mg
Pyrilamine Maleate 50 mg
Otc - Purpose
Purpose
Cough suppressant
Antihistamine
Indications & Usage
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
Warnings
Do not exceed recommended dosage.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
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
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Dosage & Administration
Directions
- Do not exceed 4 (57mL) bottles in a 24-hour period
Adults and children 12 years of age and over: | Take 1 (57mL) bottle every 6 to 8 hours |
Children under 12 years of age: | Do not use. |
Storage And Handling
Other information
- Each 57 mL bottle contains: Sodium 33 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).
- this package is child resistant
Inactive Ingredient
Inactive ingredients
Anhydrous Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.
Otc - Questions
Questions? Comments?
Call 1-888-535-0305
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