Sudafed description, usages, side effects, indications, overdosage, supplying and lots more!

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Sudafed

McNeil Consumer Healthcare Div McNeil-PPC, Inc

SUDAFED 24 HOUR


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 240 mg

Purpose

Nasal decongestant

Sudafed 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, 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

Sudafed

Sudafed

Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-669
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 240 mg

Inactive Ingredients

Ingredient Name Strength
CELLULOSE ACETATE
hydroxypropyl cellulose
HYPROMELLOSES
MAGNESIUM STEARATE
polyethylene glycol
polysorbate 80
povidone
SODIUM CHLORIDE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm SU;24 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 NDC:50580-669-10 2 in 1 CARTON

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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