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SUDAFED 12 HOUR by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Medically reviewed on Aug 18, 2017

Dosage form: tablet, film coated, extended release
Ingredients: Pseudoephedrine Hydrochloride 120mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-342

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
  • each tablet contains: calcium 45 mg
  • store at 20-25°C (68-77°F) in a dry place
  • protect from light
  • do not use if blister unit is torn or broken
  • see carton end panel for lot number and expiration date
  • this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

SINUS
NDC 50580-342-02

SUDAFED®
12 HOUR

Pseudoephedrine HCl Extended-Release Tablets, 120 mg
Long-Acting Nasal Decongestant

SINUS PRESSURE
+ CONGESTION

Pseudoephedrine
HCl

20 COATED CAPLETS*
120 mg EACH

MAXIMUM
STRENGTH

NON-DROWSY

*CAPSULE-SHAPED TABLETS
‡ Actual Size

SUDAFED 12 HOUR 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-342
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
silicon dioxide 
dibasic calcium phosphate dihydrate 
hypromellose, unspecified 
magnesium stearate 
microcrystalline cellulose 
polyethylene glycol, unspecified 
polysorbate 80 
titanium dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeSU12
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-342-011 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:50580-342-022 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07515309/01/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Further information

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

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