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 years do 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 Type HUMAN OTC DRUG Item Code (Source) NDC:50580-669
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 240 mg
Inactive Ingredients
Ingredient Name Strength
cellulose acetate (UNII: 3J2P07GVB6)  
hydroxypropyl cellulose (UNII: RFW2ET671P)  
hypromelloses (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
polyethylene glycol (UNII: 3WJQ0SDW1A)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
povidone (UNII: FZ989GH94E)  
sodium chloride (UNII: 451W47IQ8X)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code SU;24
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-669-10 2 in 1 CARTON
1 5 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020021 10/01/2008
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