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
Entex Lq
FDA Label NDC 54868-6241
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Entex Lq (NDC 54868-6241). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients per teaspoon (5 ml), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, do not take this product if you have, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
| Age | Dose |
| Adults and children over 12 years of age | 1 teaspoonful (5mL) every 4 hours; |
| Children 6 to under 12 years of age | 1/2 teaspoonful (2.5 mL) every 4 hours; |
| Children 2 to under 6 years of age | 1/4 teaspoon (1.25mL) every 4 hours |
| Children under 2 years of age | Ask 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
* Please review the disclaimer below.
