Aspirin by NORTHEAST PHARMA / GERI-CARE PHARMACEUTICAL CORP hpc 901

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by NORTHEAST PHARMA, GERI-CARE PHARMACEUTICAL CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASPIRIN- aspirin tablet, film coated 
NORTHEAST PHARMA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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hpc 901

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

• pain and fever of colds
• headache
• muscle pain
• minor pain of arthritis
• toothache
• menstrual pain

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:

• facial swelling
• shock
• hives
• 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
• 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
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug

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

• you have asthma
• 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

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:
  • have bloody or black stools
  • feel faint
  • have stomach pain that does not get better
    
  • vomit blood
• ringing in the ears or a loss of hearing occurs
  
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• drink a full glass of water with each dose
• adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredient

corn starch, hypromellose,
polyethylene glycol, propylene glycol

Questions or comments?

1-800-383-0648

Principal Display Panel

ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-901
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASPIRIN;44157
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-901-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/01/2020	09/30/2020

Labeler - NORTHEAST PHARMA (081232935)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 10/2021

Document Id: ce2c67f3-ce5a-be6a-e053-2995a90a3595

34390-5

Set id: b6abf106-159f-6e9f-e053-2995a90a55f0

Version: 2

Effective Time: 20211012