Drx. Choice Chewable Aspirin

Drug Facts

Composition & Product

Active Ingredients

Aspirin (81 mg)

Inactive Ingredients

Dextrose, Unspecified Form Starch, Corn Fd&c Yellow No. 6 Maltodextrin Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: RP81 Shape: round Color: orange Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-06-03

Medication Information

Purpose

Pain reliever

Description

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

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor.

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 over
▪
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

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 to exceed 48 tablets in 24 hours unless directed by a doctor
▪
children under 12 years: consult a doctor

Do Not Use

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

Other Information

▪
store at room temperature
▪
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, dextrose, FD&C yellow #6 aluminum lake, flavors, maltodextrin, sucralose.

Principal Display Panel

DRxChoice

compare to Bayer® Chewable Low Dose Aspirin active ingredients**

NDC 68163-081-91

low dose

CHEWABLE ASPIRIN

81 mg tablets

pain reliever (NSAID)

orange flavor

aspirin regimen

36 Chewable Tablets

3 bottles - 36 tablets each

value pack

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.

GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product.

Distributed By:

Raritan Pharmaceuticals Inc

8 Joanna Court

ASPIRIN Display artwork-1

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 are taking a diuretic
▪
you have asthma

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
▪
redness or swelling is present
▪
new symptoms occur
▪
ringing in the ears or loss of hearing occurs

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

Aspirin Artwork Label Display 2

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

•
gout
•
diabetes
•
arthritis

Structured Label Content

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor.

Purpose

Pain reliever

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 over
▪
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

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 to exceed 48 tablets in 24 hours unless directed by a doctor
▪
children under 12 years: consult a doctor

Do Not Use (Do not use)

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

Other Information (Other information)

▪
store at room temperature
▪
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, dextrose, FD&C yellow #6 aluminum lake, flavors, maltodextrin, sucralose.

Principal Display Panel

DRxChoice

compare to Bayer® Chewable Low Dose Aspirin active ingredients**

NDC 68163-081-91

low dose

CHEWABLE ASPIRIN

81 mg tablets

pain reliever (NSAID)

orange flavor

aspirin regimen

36 Chewable Tablets

3 bottles - 36 tablets each

value pack

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.

GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product.

Distributed By:

Raritan Pharmaceuticals Inc

8 Joanna Court

ASPIRIN Display artwork-1

Ask A Doctor Before Use If (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 are taking a diuretic
▪
you have asthma

Stop Use and Ask A Doctor If (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
▪
redness or swelling is present
▪
new symptoms occur
▪
ringing in the ears or loss of hearing occurs

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. (Keep out of reach of children.)

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

Aspirin Artwork Label Display 2 (ASPIRIN artwork Label Display-2)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

•
gout
•
diabetes
•
arthritis

Advanced Ingredient Data

[{"name": "ASPIRIN", "unii": "R16CO5Y76E", "classCode": "ACTIB", "strengthNumerator": "81", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of minor aches and pains or as recommended by your doctor.", "Purpose": "Pain reliever", "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 over ▪ 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", "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 to exceed 48 tablets in 24 hours unless directed by a doctor ▪ children under 12 years: consult a doctor", "Do not use": "▪ if you are allergic to aspirin or any other pain reliever/fever reducer ▪ this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor", "Other information": "▪ store at room temperature ▪ see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, dextrose, FD&C yellow #6 aluminum lake, flavors, maltodextrin, sucralose.", "Principal Display Panel": "DRxChoice compare to Bayer® Chewable Low Dose Aspirin active ingredients** NDC 68163-081-91 low dose CHEWABLE ASPIRIN 81 mg tablets pain reliever (NSAID) orange flavor aspirin regimen 36 Chewable Tablets 3 bottles - 36 tablets each value pack DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING **This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin. GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product. Distributed By: Raritan Pharmaceuticals Inc 8 Joanna Court ASPIRIN Display artwork-1", "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 are taking a diuretic ▪ you have asthma", "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 ▪ redness or swelling is present ▪ new symptoms occur ▪ ringing in the ears or loss of hearing occurs 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 overdose, In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each tablet)": "Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug", "Ask a doctor or pharmacist before use if you are": "taking a prescription drug for • gout • diabetes • arthritis"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information