ADULT LOW STRENGTH ASPIRIN- aspirin tablet, coated
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 44-414-Delisted

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
take other drugs containing prescription or nonprescription) NSAIDs [aspirin, ibuprofen, naproxen, or others]
take a blood thinning (anticoagulant) or steroid drug
take more or for a longer time than directed
have had stomach ulcers or bleeding problems
have 3 or more alcoholic drinks every day while using this product

Do not use

if you have ever had an allergic reaction to any pain reliever or fever reducer.

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
an allergic reaction occurs
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours, or as directed by a doctor.
children under 12 years: do not use unless directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºF (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-877-932-7948

Principal Display Panel

equaline®

compare to the active ingredient in
St. Joseph® Adult Strength Aspirin†

NDC 41163-414-12

adult low strength
aspirin
pain reliever (NSAID) 81 mg
safety coated for aspirin regimen users

easy-to-swallow

100 enteric coated tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DOES NOT CONTAIN GLUTEN

†This product is not manufactured or distributed by
McNeil Consumer Helathcare, owner of the registered
trademark St. Joseph® Adult Low Strength Aspirin.
50844 REV 0512C41412

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
Contact us at 1-877-932-7948, or
www.supervalu-ourownbrands.com.

Equaline 44-414A

ADULT LOW STRENGTH ASPIRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-414
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-414-12	1 in 1 CARTON	01/14/2004	03/10/2018
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:41163-414-60	1 in 1 CARTON	01/14/2004	03/10/2018
2		180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	01/14/2004	03/10/2018

Labeler - SUPERVALU INC. (006961411)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(41163-414)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(41163-414)

Revised: 7/2016

Document Id: 7643aa74-be93-4bb7-8fe9-327cd195bf2f

Set id: 32c37fdb-9b42-45d2-a86e-1e05e42ecd03

Version: 7

Effective Time: 20160711

SUPERVALU INC.