SUDAFED® 12 HOUR

SUDAFED 12 HOUR - pseudoephedrine hydrochloride tablet, film coated, extended release 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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SUDAFED®
12 HOUR

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

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

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

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

Inactive ingredients

candelilla wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. Printed with edible blue ink.

Questions or comments?

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

SINUS

NDC 50580-670-20

SUDAFED®
12 HOUR

PSEUDOEPHEDRINE HCl, EXTENDED RELEASE TABLETS,
LONG-ACTING NASAL DECONGESTANT

SINUS PRESSURE
+CONGESTION

MAXIMUM
STRENGTH

NON-DROWSY

Pseudoephedrine HCl

20 COATED CAPLETS*
120 MG EACH
‡Actual Pill Size
*CAPSULE-SHAPED TABLETS

Principal Display Panel

SUDAFED 12 HOUR 
pseudoephedrine hydrochloride   tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
povidone 
titanium dioxide 
Product Characteristics
ColorWHITEScore no score
ShapeOVALSize18mm
FlavorImprint Code SUDAFED;12;HOUR
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
150580-670-101 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
110 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (50580-670-10)
250580-670-202 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
210 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (50580-670-20)

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: 11/2010McNeil Consumer Healthcare Div. McNeil-PPC, Inc