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SUDAFED

Medically reviewed on March 5, 2018

Dosage form: tablet, coated
Ingredients: Pseudoephedrine Hydrochloride 30mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-545

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.

SUDAFED®

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 dose

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 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours
children ages 6 to 11 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
  • store between 20 - 25°C (68 - 77°F)
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, shellac, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-545-24

SUDAFED®
CONGESTION

Pseudoephedrine HCl, Nasal Decongestant

SINUS PRESSURE
+ CONGESTION

MAXIMUM
STRENGTH

24 TABLETS
30 mg EACH

‡Actual Pill Size

NON-DROWSY

SUDAFED 
pseudoephedrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-545
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
silicon dioxide 
D&C yellow NO. 10 
aluminum oxide 
FD&C red NO. 40 
FD&C yellow NO. 6 
ferrosoferric oxide 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
polyvinyl alcohol 
sodium starch glycolate type a potato 
shellac 
talc 
titanium dioxide 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeSU
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-545-243 BLISTER PACK in 1 CARTON
18 TABLET, COATED in 1 BLISTER PACK
2NDC:50580-545-723 CARTON in 1 PACKAGE
2NDC:50580-545-243 BLISTER PACK in 1 CARTON
28 TABLET, COATED in 1 BLISTER PACK
3NDC:50580-545-486 BLISTER PACK in 1 CARTON
38 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2011
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Further information

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

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