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NDC 68210-2200-03 CHEWABLE LOW DOSE 81 mg/1 Details

CHEWABLE LOW DOSE 81 mg/1

CHEWABLE LOW DOSE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by SPIRIT PHARMACEUTICALS LLC. The primary component is ASPIRIN.

MedlinePlus Drug Summary

Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by breakdown of the lining of the joints), systemic lupus erythematosus (condition in which the immune system attacks the joints and organs and causes pain and swelling) and certain other rheumatologic conditions (conditions in which the immune system attacks parts of the body). Nonprescription aspirin is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches. Nonprescription aspirin is also used to prevent heart attacks in people who have had a heart attack in the past or who have angina (chest pain that occurs when the heart does not get enough oxygen). Nonprescription aspirin is also used to reduce the risk of death in people who are experiencing or who have recently experienced a heart attack. Nonprescription aspirin is also used to prevent ischemic strokes (strokes that occur when a blood clot blocks the flow of blood to the brain) or mini-strokes (strokes that occur when the flow of blood to the brain is blocked for a short time) in people who have had this type of stroke or mini-stroke in the past. Aspirin will not prevent hemorrhagic strokes (strokes caused by bleeding in the brain). Aspirin is in a group of medications called salicylates. It works by stopping the production of certain natural substances that cause fever, pain, swelling, and blood clots. Aspirin is also available in combination with other medications such as antacids, pain relievers, and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product, read the information on the package or prescription label or ask your doctor or pharmacist for more information.

Related Packages: 68210-2200-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	68210-2200
Product ID	68210-2200_ee122adf-285e-aab8-e053-2995a90aeb95
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CHEWABLE LOW DOSE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	81
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	SPIRIT PHARMACEUTICALS LLC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68210-2200-03 (68210220003)

Pricing Information	N/A
NDC Package Code	68210-2200-3
Billing NDC	68210220003
Package	1 BOTTLE in 1 CARTON (68210-2200-3) / 36 TABLET, CHEWABLE in 1 BOTTLE
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a25d8e5c-8250-4fe6-8261-2be47afdfe75 Details

Drug Facts

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, fever or other symptoms

needing immediate relief.

■ ask your doctor about other uses for 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.

■ this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

■ 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 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

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

■ redness or swelling is present

■ new symptoms occur

■ ringing in the ears or a loss of hearing occurs

SPL UNCLASSIFIED SECTION

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, get medical help or contact a Poison

Control Center right away. 1(800)222-1222

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

Other information

■ each tablet contains: sodium 0.22 mg

■ store at room temperature

■ save carton for full directions and warnings

Inactive ingredients

BHT (Butylated Hydroxytoluene), dextrates, FD&C

Yellow #6 Aluminum Lake, microcrystalline

cellulose, modified corn starch, orange flavor,

pregelatinized starch, sucralose, stearic acid

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON

COMPARE TO THE ACTIVE INGREDIENT OF

BAYER® CHEWABLE LOW DOSE ASPIRIN†

FAMILY wellness

NDC 68210-2200-3

CHEWABLE LOW DOSE

Aspirin 81 mg

Pain Reliever (NSAID)

Aspirin Regimen

36 ORANGE FLAVORED TABLETS

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

CHEWABLE LOW DOSE

aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68210-2200
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
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ORANGE (UNII: 5EVU04N5QU)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	TCL334
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-2200-3	1 in 1 CARTON	12/01/2018
1		36 in 1 BOTTLE; 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	12/01/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 11/2022

Document Id: ee122adf-285e-aab8-e053-2995a90aeb95

Set id: a25d8e5c-8250-4fe6-8261-2be47afdfe75

Version: 10

Effective Time: 20221122

Search by Drug Name or NDC

NDC 68210-2200-03 CHEWABLE LOW DOSE 81 mg/1 Details

CHEWABLE LOW DOSE 81 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68210-2200-03 (68210220003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a25d8e5c-8250-4fe6-8261-2be47afdfe75 Details

Drug Facts

Active ingredient

(in each tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 68210-2200-03 CHEWABLE LOW DOSE 81 mg/1 Details

CHEWABLE LOW DOSE 81 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68210-2200-03 (68210220003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a25d8e5c-8250-4fe6-8261-2be47afdfe75 Details

Drug Facts

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 36 COUNT BOTTLE CARTON

INGREDIENTS AND APPEARANCE

Active ingredient

(in each tablet)