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  5. Label Information: Texaclear Kids Cough And Cold

FDA Label for Texaclear Kids Cough And Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 30 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Texaclear Kids Cough And Cold 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)



Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg


Purpose



Cough suppressant
Expectorant
Nasal decongestant


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
  • nasal congestion due to a cold  
  • stuffy nose
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings



Do not exceed recommended dosage.


Do Not Use



  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • in children under 6 years of age

Ask A Doctor Before Use If You Have



  • heart disease, thyroid disease, diabetes, or high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



taking any other oral nasal decongestant or stimulant


When Using This Product



do not use more than directed


Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days, or are accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

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 6 doses per 24-hour period

■ use enclosed (30 mL) dose cup  ■ mL = milliliter

■ dose every 4 hours

■ adults and children 12 years and over:60 mL (2 dose cups)

■ children 6 to under 12 years: 30 mL (1 dose cup)

■ children under 6 years: do not use


Other Information



  • each 30 mL contains: Sodium 15 mg
  • read all product information before using
  • store at room temperature 68-86°F (20-30°C)

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.
Arlington, TX. 76015


Principal Display Panel



TexaClear® Kids Daytime Cough & Cold
NDC 58809-950-08
8 fl. oz. (237 mL)

 

Dextromethorphan HBR – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCL – Nasal Decongestant

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

* Please review the disclaimer below.