Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 dose

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 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours
children ages 6 to 11 years	take 1 tablet every 4 to 6 hours do not take more than 4 tablets in 24 hours
children under 6 years	do not use this product in children under 6 years of age

Other information

store between 20 - 25°C (68 - 77°F)
do not use if blister unit is torn or broken
see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

PREVIOUSLY SUDAFED ® CONGESTION
NDC 50580-363-02

SUDAFED ®

SINUS
CONGESTION

Pseudoephedrine HCl 30 mg,
Nasal Decongestant

actual size

MAXIMUM STRENGTH

SINUS PRESSURE
SINUS CONGESTION

24 TABLETS

NON-DROWSY

SUDAFED SINUS CONGESTION
pseudoephedrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50580-363
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	SU
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50580-363-01	4 in 1 CARTON	07/31/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50580-363-02	2 in 1 CARTON	07/31/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:50580-363-03	3 in 1 PACKAGE	02/07/2022
3		2 in 1 CARTON
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	07/31/2021

Labeler - Johnson & Johnson Consumer Inc. (878046358)

SUDAFED Sinus Congestion