ASPIRIN LOW DOSE CHEWABLE ORANGE- aspirin tablet, chewable
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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Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommneded by your doctor
ask your doctor about other uses for Chewable Aspirin 81 mg

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
asthma (wheezing)
shock

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

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever get worse or lasts more than 3 days
redness or swelling is present
ringing in the ears or loss of hearing occurs
any new symptoms occur

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 problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of accidental 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 not exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years	consult a doctor

Other information

store at room temperature (15 0-30 0C)
Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

1-800-616-2471

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Aspirin Low Dose Chewable Orange

GENERIC: Aspirin

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-2422-0

NDC: 70518-2422-1

NDC: 70518-2422-2

NDC: 70518-2422-3

NDC: 70518-2422-4

NDC: 70518-2422-5

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: PH034

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

STARCH, CORN
STEARIC ACID
FD&C YELLOW NO. 6
SILICON DIOXIDE
SACCHARIN SODIUM
DEXTROSE MONOHYDRATE

Remedy_Label

ASPIRIN LOW DOSE CHEWABLE ORANGE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2422(NDC:0904-6794)
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)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	PH034
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-2422-0	100 in 1 BOX	11/15/2019	11/18/2019
1	NDC:70518-2422-1	1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:70518-2422-2	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/27/2020	03/30/2020
3	NDC:70518-2422-3	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/28/2020	10/13/2023
4	NDC:70518-2422-4	30 in 1 BOX	01/22/2021	01/25/2021
4	NDC:70518-2422-5	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/15/2019	10/13/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 8/2023

Document Id: 0411e8ff-334f-f09b-e063-6394a90a2bad

Set id: 45f7a703-3c80-414c-a74b-122c57ee309b

Version: 6

Effective Time: 20230829

REMEDYREPACK INC.