1. Home
  2. Labeler Index
  3. Gm Pharmaceuticals, Inc.
  4. 58809-925
  5. Label Information: Texaclear Kids Allergy

FDA Label for Texaclear Kids Allergy

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 30 ML)
    2. PURPOSE
    3. USES
    4. ASK A DOCTOR BEFORE USE IF YOU HAVE
    5. ASK A DOCTOR BEFORE USE IF YOU ARE
    6. WHEN USING THIS PRODUCT
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Texaclear Kids Allergy 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 12.5 mg
Pyrilamine Maleate 25 mg


Purpose



Cough Suppressant
Antihistamine


Uses



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

  • itchy nose or throat
  • sneezing
  • itchy, watery eyes      
  • runny nose
  • 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

▪ 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
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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 per 24 hours

▪ mL= milliliter

▪ use enclosed dose cup and keep with product

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:do not use.

Other Information



▪ each 30 mL contains: Sodium 14 mg

▪ read all product information before using

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


Inactive Ingredients



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


Questions Or Comments?



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

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

KEEP LEAFLET AFTER OPENING


Principal Display Panel



TexaClear® Kids Allergy + Cough
NDC 58809-925-08
8 fl. oz. (237 mL)

Chlophedianol HCl – Cough Suppressant
Pyrilamine Maleate – Antihistamine

Tamper evident: do not use if foil seal under cap is broken on missing

* Please review the disclaimer below.