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 years do 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 Type HUMAN OTC DRUG Item Code (Source) NDC:50580-672
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pseudoephedrine hydrochloride (pseudoephedrine) pseudoephedrine hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
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
Color RED (Film-coated) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code SU
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-672-24 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (50580-672-24)
2 NDC:50580-672-48 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (50580-672-48)
3 NDC:50580-672-96 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (50580-672-96)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/01/2008 09/30/2012

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

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