SINUS CONGESTION- pseudoephedrine hcl tablet, film coated
L. Perrigo Company

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Perrigo Sinus Congestion 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 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 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

•: each tablet contains: calcium 20 mg
•: store at 20°-25°C (68°-77°F)
•: do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® Congestion active ingredient

MAXIMUM STRENGTH

sinus congestion

Pseudoephedrine HCl Tablets

Nasal Decongestant

CONGESTION

Sinus Pressure + Congestion

Non-Drowsy

Actual Size

96 TABLETS

(30 mg each)

SINUS CONGESTION
pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-2008
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	7mm
Flavor		Imprint Code	L432
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0113-2008-80	48 in 1 CARTON	10/04/2016	07/31/2020
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0113-2008-67	24 in 1 CARTON	10/04/2016	02/29/2020
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0113-2008-62	12 in 1 CARTON	10/04/2016	10/04/2016
3		2 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	10/04/2016	07/31/2020

Labeler - L. Perrigo Company (006013346)

Revised: 2/2024

Document Id: b6908caf-e974-4032-a6c5-26c01b0f7e29

Set id: 2dd0e007-4aeb-4b51-815e-4ebe378a4095

Version: 4

Effective Time: 20240221

L. Perrigo Company