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

----------

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 years do 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 Type HUMAN OTC DRUG NDC Product Code (Source) 50580-670
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride 120 mg
Inactive Ingredients
Ingredient Name Strength
candelilla wax  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polyethylene glycol  
povidone  
titanium dioxide  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code SUDAFED;12;HOUR
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50580-670-10 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-670-10)
2 50580-670-20 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK
2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (50580-670-20)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073585 06/01/2008

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)
Revised: 11/2010 McNeil Consumer Healthcare Div. McNeil-PPC, Inc