SUDAFED® MAXIMUM STRENGTH Nasal Decongestant

SUDAFED NASAL DECONGESTANT MAXIMUM STRENGTH - pseudoephedrine hydrochloride tablet 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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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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 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

carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #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

PRINCIPAL DISPLAY PANEL

NDC 50580-672-24

Non-Drowsy
SUDAFED
®

MAXIMUM STRENGTH
NASAL DECONGESTANT

Pseudoephedrine HCl tablets • Nasal decongestant

12 DOSES
2 Pills/Dose

24 TABLETS
30 mg EACH

Principal Display Panel

SUDAFED NASAL DECONGESTANT  MAXIMUM STRENGTH
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-672
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 
FD&C red no. 40 
FD&C yellow no. 6 
aluminum oxide 
ferrosoferric oxide 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
polyvinyl alcohol 
shellac 
sodium starch glycolate type A potato 
talc 
titanium dioxide 
Product Characteristics
ColorRED (Film-coated) Score no score
ShapeROUNDSize7mm
FlavorImprint Code SU
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50580-672-241 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
124 TABLET in 1 BLISTER PACKThis package is contained within the CARTON (50580-672-24)
2NDC:50580-672-482 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
224 TABLET in 1 BLISTER PACKThis package is contained within the CARTON (50580-672-48)
3NDC:50580-672-964 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
324 TABLET in 1 BLISTER PACKThis package is contained within the CARTON (50580-672-96)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/200809/30/2012

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 08/2012 McNeil Consumer Healthcare Div McNeil-PPC, Inc