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Sudafed 12 Hour by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Dosage form: tablet, film coated, extended release
Ingredients: Pseudoephedrine hydrochloride 120mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-670

SUDAFED®
12 HOUR

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

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

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

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 1 tablet every 12 hours
  • do not take more than 2 tablets in 24 hours
children under 12 yearsdo not use this product in children under 12 years of age

Other information
  • store at 59° to 77°F in a dry place. Protect from light
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

candelilla wax, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac, talc, titanium dioxide

Questions or comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-670-20

SUDAFED®
12 HOUR

Pseudoephedrine HCl Extended-Release Tablets,
Long-Acting Nasal Decongestant

SINUS PRESSURE
+ CONGESTION

Pseudoephedrine
HCl

MAXIMUM
STRENGTH

NON-DROWSY

20 COATED CAPLETS*
120 mg EACH

*CAPSULE-SHAPED TABLETS
‡Actual Pill Size

SUDAFED 12 HOUR 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-670
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
candelilla wax 
FD&C blue no. 1 
aluminum oxide 
HYPROMELLOSE, UNSPECIFIED 
magnesium stearate 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
propylene glycol 
shellac 
talc 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint CodeSUDAFED;12;HOUR
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-670-101 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:50580-670-303 CARTON in 1 PACKAGE
2NDC:50580-670-101 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:50580-670-202 BLISTER PACK in 1 CARTON
310 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07358506/01/2008
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Medically reviewed on Jul 19, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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