RxNorm Names
ENTEX T
(guaifenesin and pseudoephedrine hydrochloride)
tablet
[WraSer Pharmaceuticals, LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1c5bff62-239b-449c-afc1-9a0e07c72bd0| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE: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.
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies (allergic rhinitis)
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
Warnings
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by excessive phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur.
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Do not exceed 4 doses in a 24 hour period
- Adults and children 12 years of age and over: 1 tablet every 4 hours.
- Children 6 to under 12 years of age: 1/2 tablet every 4 hours.
Other information
- store at 20°- 25°C (68°- 77°F)
- tamper evident: do not use if foil seal under the cap is broken or missing.
- contains 4 mg sodium in each tablet
- contains less than 1 mg magnesium in each tablet
Inactive Ingredients
croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and starch.
| ENTEX T
guaifenesin and pseudoephedrine hydrochloride tablet |
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| Labeler - WraSer Pharmaceuticals, LLC (121828334) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Sovereign Pharmaceuticals, LLC | 623168267 | MANUFACTURE(66992-281) | |
Revised: 11/2012
Document Id: faf50d93-ff0d-464b-89e2-ff2abe2cc2fb
Set id: 1c5bff62-239b-449c-afc1-9a0e07c72bd0
Version: 3
Effective Time: 20121108
WraSer Pharmaceuticals, LLC
Review RxNorm Normal Forms