PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hcl tablet, film coated, extended release 
REMEDYREPACK INC.

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Perrigo Pseudoephedrine Hydrochloride 120 mg Drug Facts

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?

1-800-719-9260

DRUG: pseudoephedrine hydrochloride

GENERIC: Pseudoephedrine HCl

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-1618-0

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 18 mm

IMPRINT: L054

PACKAGING: 1 in 1 BLISTER PACK

OUTER PACKAGING: 10 in 1 CARTON

ACTIVE INGREDIENT(S):

  • PSEUDOEPHEDRINE HYDROCHLORIDE 120mg in 1

INACTIVE INGREDIENT(S):

  • CARNAUBA WAX
  • SILICON DIOXIDE
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE
  • HYPROMELLOSE, UNSPECIFIED
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • POLYSORBATE 80
  • TITANIUM DIOXIDE

MM1

PSEUDOEPHEDRINE HYDROCHLORIDE 
pseudoephedrine hcl tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1618(NDC:45802-107)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code L054
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1618-01 in 1 CARTON10/30/201909/01/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515310/30/201909/01/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2022
Document Id: ebcb5b58-42f8-fad7-e053-2995a90aac34
Set id: ed560e21-20ca-42d6-a745-b1551aabe957
Version: 8
Effective Time: 20221024
 
REMEDYREPACK INC.