Aspirin by REMEDYREPACK INC. Rugby 44-157

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASPIRIN- aspirin tablet, delayed release 
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.

----------

Rugby 44-157

Active ingredient (in each tablet)

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

Purpose

Pain reliever/fever reducer 

Uses

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

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:

• shock
• facial swelling
• 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
• 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
• 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 asthma
• 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:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• 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
• new symptoms occur
• redness or swelling is present

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 or 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. 

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

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• use by expiration date on package
  

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol 

Questions or comments?

1-800-645-2158 

DRUG: Aspirin

GENERIC: Aspirin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-3069-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;157;ASPIRIN

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• ASPIRIN 325mg in 1

INACTIVE INGREDIENT(S):

• STARCH, CORN
• HYPROMELLOSE, UNSPECIFIED
• PROPYLENE GLYCOL
• POLYETHYLENE GLYCOL, UNSPECIFIED

ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-3069(NDC: 0536-1054)
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;157;ASPIRIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-3069-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/10/2021	05/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/10/2021	05/03/2021

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023

Document Id: 0799ae24-7a92-87bb-e063-6394a90aa1c5

34390-5

Set id: 3919f366-5675-45df-b808-8e1477c0c163

Version: 2

Effective Time: 20231013