DURAVENT PE- guaifenesin and phenylephrine hydrochloride tablet 
Allegis 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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Duravent™ PE

Drug Facts

Active ingredients (in each tablet)Purpose
Guaifenesin 395 mgExpectorant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • 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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if you have

  • a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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.
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

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 recommended dosage.

Adults and Children 12 years of age and older:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours
Childen 6 to under 12 years of age:½ tablet every 4 hours, not to exceed 3 tablets in 24 hours
Children under 6 years of age:Consult a physician.

Other Information

Store at 15°-30° C (59°-86° F).

Tamper evident by foil seal under cap.

Do not use if foil seal is missing or broken.

Dispense in a tight, light-resistant container with a child resistant cap.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1 aluminum lake, hypromellose, maltodextrin, povidone, sillicified microcrystalline cellulose, and stearic acid.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC 28595-905-60

Expectorant • Nasal Decongestant

DURAVENT™PE

Each tablet contains:
Guaifenesin           395 mg
Phenylephrine HCl  10 mg

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for: Allegis Pharmaceuticals, LLC
Canton, MS 39046

60 Tablets

Principal Display Panel - 60 Tablet Bottle Label
DURAVENT PE 
guaifenesin and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-905
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN395 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVAL (capsule-shaped) Size16mm
FlavorImprint Code 905
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28595-905-6060 in 1 BOTTLE; Type 0: Not a Combination Product02/27/201412/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/27/201412/31/2019
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 1/2020
 
Allegis Pharmaceuticals, LLC