Pseudoephedrine hcl tablet, extended release

Drug facts

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

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsons 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 36 mg
  • store at 20 to 25C (68 to 77F). 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:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

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

Ingredients and appearance - Product information

Pseudoephedrine hcl tablet, extended release- Pseudoephedrine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-804
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Pseudoephedrine hydrochloride ( UNII: 6V9V2RYJ8N)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 120 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Hydroxypropyl cellulose (90000 wamw) ( UNII: UKE75GEA7F)
Hypromellose 2208 (15000 mpa.s) ( UNII: Z78RG6M2N2)
Hypromellose 2208 (4000 mpa.s) ( UNII: 39J80LT57T)
Hypromellose 2910 (5 mpa.s) ( UNII: R75537T0T4)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (White to Off-white) Shape CAPSULE
Size 18 mm Score 1
Imprint Code 70;T

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA209008 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-804), MANUFACTURE( 58602-804)

Package label-principal display panel - 120 mg, blister carton 20 (2 x 10)extended-release tablets

AUROHEALTH
Compare to the active ingredient in
Sudafed ®12 Hour**
NDC 58602-804-67
MAXIMUM STRENGTH
Long-Acting Nasal Decongestant
Pseudoephedrine HCl
Extended-Release Tablets USP 120 mg

SINUS PRESSURE
CONGESTION
NON-DROWSY
12 HOUR
20 COATED CAPLETS*
120 mg EACH
*CAPSULE-SHAPED TABLETS