Nasal Decongestant Pe Tablet
FDA Label NDC 37835-651

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Nasal Decongestant Pe (NDC 37835-651). 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 ingredient (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Phenylephrine HCl 10mg

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

Warnings

Do not use ifyou 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 taking this product.

Ask A Doctor Before Use If You Have

  • 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
  • symptoms do not improve within 7 days or occur with a fever.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.

Directions

  • adults and children 12 years and over:take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years:ask a doctor

Other Information

  • each tablet contains:phosphorus 10 mg
  • store between 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose

Questions?

call toll free 1-844-912-4012

Other

Distributed by:

BI-MART

Eugene, OR 97402

Principal Display Panel-36 Count

NDC 37835-651-36

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

36 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

Label (Label 36)

Label (Label 36)

Principal Display Panel-100 Count

NDC 37835-651-01

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ®Sinus Congestion.

Label (Label 100)

Label (Label 100)

* Please review the disclaimer below.