PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated 
REMEDYREPACK INC.

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Pseudoephedrine hydrochloride

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

Other information

  • store at 59° to 77° F in a dry place. Protect from light
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive ingredients

castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?

call 1-800-406-7984

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Pseudoephedrine hydrochloride

GENERIC: Pseudoephedrine hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-3405-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: 204

PACKAGING: 10 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • PSEUDOEPHEDRINE HYDROCHLORIDE 120mg in 1

INACTIVE INGREDIENT(S):

  • CASTOR OIL
  • SILICON DIOXIDE
  • HYPROMELLOSE, UNSPECIFIED
  • MICROCRYSTALLINE CELLULOSE
  • MAGNESIUM STEARATE
  • TITANIUM DIOXIDE

Remedy_Label

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3405(NDC:51660-204)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code 204
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3405-010 in 1 BLISTER PACK; Type 0: Not a Combination Product04/07/202210/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744204/07/202210/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07d815ea-8595-ea8f-e063-6294a90ac84d
Set id: a95c18ed-564d-4e77-ac4a-98a9e47df92f
Version: 2
Effective Time: 20231016
 
REMEDYREPACK INC.