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SudoGest by REMEDYREPACK INC.

Dosage form: tablet, film coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0121

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.

Major 44-112

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 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 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • 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 years
do not use this product
in children under 6 years
of age

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

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?

(800) 616-2471

DRUG: SudoGest

GENERIC: Pseudoephedrine HCl

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0121-0

COLOR: red

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: 44;112

PACKAGING: 30 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 1

INACTIVE INGREDIENT(S):

  • CROSCARMELLOSE SODIUM
  • POLYETHYLENE GLYCOLS
  • POLYDEXTROSE
  • TITANIUM DIOXIDE
  • FD&C YELLOW NO. 6
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • TRIACETIN

SUDOGEST 
pseudoephedrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0121(NDC:0904-5053)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;112
Contains    
Packaging
#Item CodePackage Description
1NDC:70518-0121-030 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/17/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Medically reviewed on Nov 2, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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