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SUDAFED

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

SUDAFED®


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

SUDAFED Uses

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

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 11 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

SUDAFED Other information

  • store between 20 - 25°C (68 - 77°F)
  • do not use if carton or blister unit is opened or broken
  • see side panel for lot number and expiration date

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

SINUS

NDC 50580-545-24

SUDAFED ®
CONGESTION

PSEUDOEPHEDRINE HCl, TABLETS, NASAL DECONGESTANT

SINUS PRESSURE
+CONGESTION

Pseudoephedrine HCl

MAXIMUM
STRENGTH

24 TABLETS
30 MG EACH
‡Actual Pill Size

NON-DROWSY

SUDAFED

SUDAFED

Pseudoephedrine Hydrochloride TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-545
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
SILICON DIOXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
SHELLAC
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 7 mm SU ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 8 in 1 BLISTER PACK
4 8 in 1 BLISTER PACK
5 NDC:50580-545-96 12 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-10-01


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Be sure to consult your doctor before taking any medication!
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