SUDAFED 24 HOUR- pseudoephedrine hydrochloride tablet, extended release

Sudafed by

Drug Labeling and Warnings

Sudafed by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 240 mg

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• reduces swelling of nasal passages
• relieves sinus pressure

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

• each tablet contains: sodium 10 mg
• store at 15° to 25°C (59° to 77°F) in a dry place.
• do not use if carton is opened or if individual blister seals are broken or opened
• see side panel for lot number and expiration date

Inactive ingredients

cellulose triacetate, hydroxypropylcellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, propylene glycol, shellac, 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

INGREDIENTS AND APPEARANCE

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

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
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
magnesium stearate (UNII: 70097M6I30)
microcrystalline cellulose (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
polysorbate 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
propylene glycol (UNII: 6DC9Q167V3)
shellac (UNII: 46N107B71O)
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	10/01/2008
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020021	10/01/2008

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)