ASPIRIN tablet, chewable

aspirin by

Drug Labeling and Warnings

aspirin by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains

• for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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

•  pain gets worse or lasts more than 10 days
•  fever gets worse or lasts more than 3 days
•  redness or swelling is present in the painful area
•  any new symptoms appear
•  ringing in the ears or a loss of hearing occurs

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
• you have not been drinking fluids
• you have lost a lot of
  fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug

under a doctor’s care for any serious condition

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
• shock
• facial swelling
• 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
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescritpion 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

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.

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

• store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º-86ºF)

• use by expiration date on package

Keep out of reach of children

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

Inactive Ingredients

 BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid

Questions or comments? (800) 616-2471

Distributed by:

MAJOR®  PHARMACEUTICALS

17177 N Laurel Park Dr.,Suite 233

Livonia, MI 48152 USA

M-14

L700313.01 Rev. 03/17

Principal Display Panel

 

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-7863(NDC:0904-6288)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
ORANGE (UNII: 5EVU04N5QU)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	UPPER;tcl334;LOWER;PLAIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-7863-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/19/2018	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	06/19/2018	07/31/2020

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	REPACK(0615-7863)