NASAL DECONGESTANT MAXIMUM STRENGTH- pseudoephedrine hcl tablet 
A-S Medication Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunmark 44-112

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if

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

Directions

adults and children
12 years and older 
take 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
24 hours 
children ages
6 to 12 years
take 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours 
children under 6 yearsdo not use this product in children
under 6 years of age 

Other information

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

HOW SUPPLIED

Product: 50090-3585

NDC: 50090-3585-3 30 TABLET in a BOTTLE

Pseudoephedrine HCl

Label Image
NASAL DECONGESTANT  MAXIMUM STRENGTH
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3585(NDC:70677-0005)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;112
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-3585-330 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/25/1981
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-3585) , REPACK(50090-3585)

Revised: 1/2020
Document Id: 5a72f3e8-260f-4496-8168-88ed972a4677
Set id: 50e2d7d1-fc0f-4d78-a6e9-574e2abdd76a
Version: 3
Effective Time: 20200118
 
A-S Medication Solutions