SUDAFED- pseudoephedrine hydrochloride tablet, coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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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SUDAFED®

Drug Facts

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

  • 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

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

Principal Display Panel
SUDAFED 
pseudoephedrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-545
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
carnauba wax (UNII: R12CBM0EIZ)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
D&C yellow NO. 10 (UNII: 35SW5USQ3G)  
aluminum oxide (UNII: LMI26O6933)  
FD&C red NO. 40 (UNII: WZB9127XOA)  
FD&C yellow NO. 6 (UNII: H77VEI93A8)  
ferrosoferric oxide (UNII: XM0M87F357)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
polyvinyl alcohol, unspecified (UNII: 532B59J990)  
shellac (UNII: 46N107B71O)  
sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code SU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-545-243 in 1 CARTON07/13/2015
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-545-723 in 1 PACKAGE02/29/2016
2NDC:50580-545-243 in 1 CARTON
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-545-486 in 1 CARTON07/13/2015
38 in 1 BLISTER PACK; Type 0: Not a Combination Product
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)

Revised: 12/2019
Document Id: 0243c7ca-77fa-4189-bce2-ada15361b6cb
Set id: d280abe9-6bdf-4e1e-a0cf-95fd0451c999
Version: 6
Effective Time: 20191206
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division