Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 21130-158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Pseudoephedrine Hcl (NDC 21130-158). 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, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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 USP 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

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

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 36 mg
  • store at 20° to 25°C (68° to 77°F). Protect from light.
  • do not use if the individual blister unit is open or torn
  • see side panel for lot number and expiration date
  • Meets USP dissolution test 4

Inactive Ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide.

Questions Or Comments?

call 1-855-274-4122

DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O.BOX 99
PLEASANTON, CA 94566-0009
‡1-888-723-3929

Made in India
Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 120 Mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

Compare to the
Sudafed® 12 Hour** 
active ingredient

NDC 21130-158-67

12 HOUR
MAXIMUM STRENGTH

Long-Acting
Nasal Decongestant
PSEUDOEPHEDRINE HCl
Extended-Release Tablets USP
120 mg

•  SINUS PRESSURE
•  CONGESTION
•  NON-DROWSY

20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS




Package Label-principal Display Panel (120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets)

Package Label-principal Display Panel (120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets)



* Please review the disclaimer below.