ASPIRIN LOW DOSE- aspirin tablet, delayed release
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Major 44-600A

Active ingredient
(in each tablet)

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

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor.
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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

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

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

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

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

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
ringing in the ears or a loss of hearing occurs
new symptoms occur
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems 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

do not take more than directed
drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

Other information

use by expiration date on package
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

(800) 616-2471

DRUG: AspirinLow Dose Low Dose

GENERIC: Aspirin

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2668-0

NDC: 70518-2668-1

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: L

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

TRIETHYL CITRATE
TITANIUM DIOXIDE
TALC
SODIUM LAURYL SULFATE
SODIUM BICARBONATE
WATER
DIMETHICONE
SILICON DIOXIDE
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYDEXTROSE
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID
HYPROMELLOSE, UNSPECIFIED
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
TRIACETIN
SHELLAC

MM2

ASPIRIN LOW DOSE
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2668(NDC:0904-6751)
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHACRYLIC ACID (UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	L
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-2668-0	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/03/2020	12/17/2020
2	NDC:70518-2668-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/24/2020	10/13/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/03/2020	10/13/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023

Document Id: dc89786f-2298-d2e8-e053-2995a90a44f8

Set id: efd8cc6b-6c4c-46e6-acf4-772571801fde

Version: 3

Effective Time: 20231013

REMEDYREPACK INC.