NASAL DECONGESTANT MAXIMUM STRENGTH- pseudoephedrine hcl tablet
SUPERVALU INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Equaline 44-112-Delisted

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 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

thyroid disease
diabetes
heart disease
high blood pressure
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 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.

Directions

adults and children 12 years and older	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 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 at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin

Questions or comments?

1-877-932-7948

Principal Display Panel

EQUALINE®

NDC 41163-112-08

compare to
Sudafed® Congestion
active ingredient*

maximum strength
nasal decongestant

pseudoephedrine hydrochloride tablets, 30 mg
(nasal decongestant)

non-drowsy
pseudoephedrine HCl

relieves:
• nasal & sinus congestion
• sinus pressure

24 tablets, 30mg each

actual size

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

SUPERVALU QUALITY
Guaranteed

We’re committed to your
satisfaction and guarantee
the quality of this product.
Contact us at 1-877-932-7948, or
www.supervalu-ourownbrands.com.
Please have package available.

DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Sudafed® Congestion. 50844 REV0712B11208

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

Equaline 44-112

NASAL DECONGESTANT MAXIMUM STRENGTH
pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-112
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)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-112-08	1 in 1 CARTON	08/25/1981	08/06/2021
1		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 final	part341	08/25/1981	08/06/2021

Labeler - SUPERVALU INC. (006961411)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(41163-112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(41163-112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(41163-112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(41163-112)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(41163-112)

Revised: 8/2021

Document Id: 03a9ec67-8e2c-4d9c-b8e9-d391a2761917

Set id: 20e3117b-4d9a-4fb4-b301-b6d9abc71dd9

Version: 13

Effective Time: 20210827

SUPERVALU INC.