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

Sudafed 12 Hour by

Drug Labeling and Warnings

Sudafed 12 Hour by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUDAFED 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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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

Principal Display Panel
SUDAFED 12 HOUR 
pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50580-670
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine hydrochloride120 mg
Inactive Ingredients
Ingredient NameStrength
candelilla wax (UNII: WL0328HX19)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
aluminum oxide (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
propylene glycol (UNII: 6DC9Q167V3)  
shellac (UNII: 46N107B71O)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code SUDAFED;12;HOUR
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50580-670-101 in 1 CARTON06/01/200804/30/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 50580-670-303 in 1 PACKAGE01/18/201307/31/2017
2NDC: 50580-670-101 in 1 CARTON
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 50580-670-202 in 1 CARTON06/01/200806/30/2019
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07358506/01/200806/30/2019
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 1/2020
Document Id: b59d143f-9b58-4a95-bcb3-b1b597a062a5
Set id: a110069f-dd9e-45ad-b7db-c5a6be1a1564
Version: 10
Effective Time: 20200123
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division