Sudafed 12 Hour

Dosage form: tablet, film coated, extended release
Ingredients: Pseudoephedrine hydrochloride 120mg
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
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 open 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 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycols 
povidone 
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 - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 04/2013
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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