ENTEX PAC
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guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide
WraSer Pharmaceuticals, LLC
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.
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Active Ingredients
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
Purpose
Guaifenesin, USP Expectorant
Pseudoephedrine HCl, USP Nasal decongestant
Dextromethorphan HBr, USP Antitussive
Uses
Use for Entex-T tablet:
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- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
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- for the temporary relief of nasal and sinus congestion due to cold, hay fever or other respiratory allergies
Use for Entex-S liquid:
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- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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
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- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompanied by excessive phlegm (mucus).
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- a cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur.
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- symptoms do not improve within 7 days or are accompanied by fever.
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- 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.
Do not take this product if you have
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to enlarged prostate gland
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- breathing problems such as emphysema or chronic bronchitis.
If pregnant or breast-feeding,
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- ask a health professional before use.
Keep out of reach of children
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- In case of overdose, get medical help or contact a Poison Control Center immediately.
Directions
Directions for use, Entex-T tablets:
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- Take every 4 to 6 hours
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- do not exceed 4 doses in 24 hours
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- Adults and children 12 years of age and over: 1 tablet
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- 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 |
Other information
- ∙
- store at 20°- 25°C (68°- 77°F)
Inactive ingredients
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
Questions or Comments?
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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Part 1 of 2 |
ENTEX T
guaifenesin and pseudoephedrine hydrochloride tablet |
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Part 2 of 2 |
ENTEX S
dextromethorphan hydrobromide liquid |
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Revised: 09/2011 WraSer Pharmaceuticals, LLC