FDA Label for Entex Lq

View Indications, Usage & Precautions

Entex Lq Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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 Per Teaspoon (5 Ml)



Guaifenesin, USP                             100 mg

Phenylephrine HCl, USP                   10 mg

in each 5 mL (1 teaspoonful) red, strawberry flavored liquid


Purpose



Guaifenesin, USP                               Expectorant

Phenylephrine HCl, USP                   Nasal decongestant


Uses



  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • for the temporary relief of nasal and sinus congestion due to cold, hay fever or other respiratory allergies

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 two 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 drug.


Ask A Doctor Before Use If You Have



  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompanied by excessive phlegm (mucus).

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur.
  • symptoms do not improve within 7 days or are accompanied by fever.
  • a cough persists for more than 1 week or is accompanied by a fever, rash or persistent headache.

Do Not Take This Product If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • breathing problems such as emphysema or chronic bronchitis.

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 immediately.

Directions



AgeDose
Adults and children over 12 years of age1 teaspoonful (5mL) every 4 hours;
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 hours;
Children 2 to under 6 years of age1/4 teaspoon (1.25mL) every 4 hours
Children under 2 years of ageAsk your doctor
Do not exceed 6 doses in a 24 – hour period.

Other Information



  • store at 20°- 25°C (68°- 77°F)

Inactive Ingredients



benzoic acid USP, Bitter Masking agent, citric acid USP, D&C Red #33, edetate disodium, glycerin USP, propylene glycol USP, purified water, sodium citrate dihydrate USP, sorbitol solution and strawberry flavor.


Questions Or Comments?



Call weekdays from 9 AM to 4PM CST at 1-888-252-3901 or go to http://www.wraser.com

email:[email protected]


Package Label.Principal Display Panel



ENTEX LQ (guaifenesin and phenylephrine hydrochloride) liquid473 mL (5 mL per teaspoon)NDC 54868-6241-0

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