DailyMed - SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

NDC Code(s): 11822-0112-2, 11822-0112-8
Packager: Rite Aid Corporation

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 7, 2025

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Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg

Pseudoephedrine HCl 30 mg
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Purpose
Nasal decongestant

Nasal decongestant
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Uses
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
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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 ...
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
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the 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 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.

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Directions

adults and children 12 years and overtake 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours - children ages 6 to 11 yearstake 1 tablet every 4 to 6 hours; do not take ...

Other information
each tablet contains: calcium 15 mg - TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN - store at 25°C (77°F); excursions permitted between 15°-30°C ...
- each tablet contains: calcium 15 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
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Inactive ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose ...

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin
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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal Display Panel
Compare to the active ingredient in - Sudafed® Sinus Congestion* NDC 11822-0112-8 - MAXIMUM STRENGTH - SINUS PRESSURE & CONGESTION RELIEF - PSEUDOEPHEDRINE HCl 30 mg - NASAL ...

Compare to the active ingredient in
Sudafed® Sinus Congestion*

NDC 11822-0112-8

MAXIMUM STRENGTH
SINUS PRESSURE &
CONGESTION RELIEF

PSEUDOEPHEDRINE HCl 30 mg

NASAL DECONGESTANT

NON-DROWSY

Relieves sinus pressure, nasal and sinus congestion

ACTUAL SIZE

24
TABLETS

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Kenvue Inc., owner of the
registered trademark Sudafed® Sinus Congestion.
50844 REV0619D11208

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com

SATISFACTION
GUARANTEE
If you're not satisfied, we'll
happily refund your money

Rite Aid 44-112

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INGREDIENTS AND APPEARANCE

Product Information

SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0112
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	44;112
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0112-8	1 in 1 CARTON	08/25/1981
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11822-0112-2	2 in 1 CARTON	08/25/1981
2		24 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	08/25/1981

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(11822-0112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(11822-0112) , pack(11822-0112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(11822-0112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(11822-0112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(11822-0112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(11822-0112)

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Label: SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

	NDC
1	11822-0112-2
2	11822-0112-8

Label: SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

Number of versions: 14

SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

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SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH- pseudoephedrine hcl tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.