Equaline 12 Hour Decongestant Tablet, Film Coated, Extended Release
FDA Label NDC 41163-054

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Equaline 12 Hour Decongestant (NDC 41163-054). 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, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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)

Pseudoephedrine HCl 120 mg

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

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 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

When Using This Product

do not exceed recommended dosage

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

adults and children 12 years and over

  • take 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours

children under 12 years

do not use this product in children under 12 years of age

Other Information

  • each tablet contains: calcium 45 mg
  • store at 20° - 25°C (68° - 77°F) in a dry place
  • protect from light
  • do not use if blister unit is broken or torn
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

1-877-932-7948

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compare to Sudafed® 12 Hour active ingredient

maximum strength – sinus

12 hour decongestant

pseudoephedrine hydrochloride extended release tablets, 120mg

(long-acting nasal decongestant)

non-drowsy

pseudoephedrine HCl

sinus pressure

congestion

20 coated caplets* 120mg each

*capsule-shaped tablets

actual size

* Please review the disclaimer below.