Entex PAC
Dosage form: kit
Ingredients: GUAIFENESIN 375mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg; DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL
Labeler: WraSer Pharmaceuticals, LLC
NDC Code: 66992-285
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Facts
Active ingredients for each Entex-T tablet:
Guaifenesin, USP 375 mg
Pseudoephedrine HCl, USP 60 mg
Active ingredients for each 5 mL (1 teaspoonful) Entex-S liquid:
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP Expectorant
Pseudoephedrine HCl, USP Nasal decongestant
Dextromethorphan HBr, USP Antitussive
Use for Entex-T tablet:
- 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
Use for Entex-S liquid:
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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.
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompanied by excessive phlegm (mucus).
- a cough that occurs with too much phlegm (mucus)
- 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. These could be signs of a serious condition.
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- breathing problems such as emphysema or chronic bronchitis.
- ask a health professional before use.
- In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions for use, Entex-T tablets:
- Take every 4 to 6 hours
- do not exceed 4 doses in 24 hours
- Adults and children 12 years of age and over: 1 tablet
- Children 6 to under 12 years of age: 1/2 tablet
Directions for use, Entex-S liquid:
do not take more than 4 doses in any 24-hour period
| Age | Dose |
| Adults and children 12 years of age and over: | 1 teaspoon every 4 hours |
| Children 6 to under 12 years of age: | 1/2 teaspoon every 4 hours |
- store at 20°- 25°C (68°- 77°F)
Inactive ingredients for Entex-T tablet:
croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and starch.
Inactive ingredients for Entex-S liquid:
Benzoic acid, editate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution and strawberry flavoring
Call weekdays from 9 AM to 4PM CST at 1-888-252-3901 or go to http://www.wraser.com
email:medicalinfo@wraser.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Figure 1: Entex PAC carton
| ENTEX PAC
guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide kit |
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| Labeler - WraSer Pharmaceuticals, LLC (121828334) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sovereign Pharmaceuticals, LLC | 623168267 | MANUFACTURE(66992-285) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
