SUDAFED 24 HOUR- pseudoephedrine hydrochloride tablet, extended release 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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SUDAFED®
24 HOUR

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 240 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
  • had obstruction or narrowing of the bowel. Rarely, tablets of this kind may cause bowel obstruction (blockage), usually in people with severe narrowing of the bowel (esophagus, stomach or intestine).

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • you experience persistent abdominal pain or vomiting

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
  • swallow one whole tablet with water every 24 hours
  • do not exceed one tablet in 24 hours
  • do not divide, crush, chew or dissolve the tablet
  • the tablet does not completely dissolve and may be seen in the stool (this is normal)
children under 12 yearsdo not use this product in children under 12 years of age

Other information

Inactive ingredients

cellulose, cellulose acetate, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium chloride, and titanium dioxide

Questions or comments?

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-669-10

SUDAFED®
24 HOUR

PSEUDOEPHEDRINE HCl, EXTENDED RELEASE TABLETS,
LONG-ACTING NASAL DECONGESTANT

SINUS PRESSURE
+CONGESTION

Pseudoephedrine
HCl

MAXIMUM
STRENGTH

10 TABLETS
240 MG EACH
‡Actual Pill Size

NON-DROWSY

Principal Display Panel
SUDAFED  24 HOUR
pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-669
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine Hydrochloride (pseudoephedrine) Pseudoephedrine Hydrochloride240 mg
Inactive Ingredients
Ingredient NameStrength
cellulose acetate 
hydroxypropyl cellulose 
hypromelloses 
magnesium stearate 
polyethylene glycol 
polysorbate 80 
povidone 
sodium chloride 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code SU;24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-669-102 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02002110/01/2008
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 9/2010
Document Id: d97b7d59-8ac5-4759-95e9-cbd604c7f8e4
Set id: 9991599a-b49b-4ea6-a6e1-c05f0c992f71
Version: 1
Effective Time: 20100916
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc