1. Home
  2. Labeler Index
  3. Gm Pharmaceuticals, Inc
  4. 58809-216
  5. Label Information: Texaclear Kids Daytime Cough And Chest Congestion

FDA Label for Texaclear Kids Daytime Cough And Chest Congestion

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 15 ML)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Texaclear Kids Daytime Cough And Chest Congestion 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 15 Ml)



Dextromethorphan HBr 5 mg
Guaifenesin 100 mg


Purpose



Cough suppressant
Expectorant


Uses



  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • temporarily relieves:
    • the intensity of coughing
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Do Not Use



in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, pschiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


Ask A Doctor Before Use If The Child Has



  • persistent or chronic cough such as occurs with asthma
  • a cough that occurs with too much phlegm (mucus)
  • a sodium-restricted diet

Stop Use And Ask A Doctor If



cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.


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 6 doses per 24-hour period.
  • measure only with the dosing cup provided.
  • mL= milliliter
    • AgeDose
    children 6 years to under 12 years30 mL (2 dose cups) every 4 hours
    children 4 years to under 6 years15 mL (1 dose cup) every 4 hours
    children under 4 yearsdo not use.

Other Information



  • each 15 mL contains: Sodium 7.5 mg
  • store at room temperature 20-30°C (68-86°F)

Inactive Ingredients



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


Questions Or Comments?



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

Distributed by:
GM Pharmaceuticals, Inc.
Fort Worth, TX. 76118


* Please review the disclaimer below.