Aspirin by Rugby Laboratories / LNK International, Inc. ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

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
• 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

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

Inactive ingredient

corn starch

Questions or comments?

1-800-645-2158

Principal Display Panel

NDC: 0536-1053-01

Rugby®

ASPIRIN
Pain Reliever/
Fever Reducer
(NSAID)

325 mg each

100 Tablets

Talk to your doctor or other healthcare provider before using this product for your heart.

AID FOR
RELIEF OF
SIMPLE HEADACHE,
COLD DISCOMFORTS,
MUSCULAR ACHES

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233 
Livonia, MI 48152     www.rugbylaboratories.com 
R-17    Re-order No. 370395 Rev. 06/18

50844        REV0318B24912

Rugby 44-249

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1053
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)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASPIRIN;44;249
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1053-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/04/1993	12/19/2021
2	NDC: 0536-1053-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/04/1993	12/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	08/04/1993	12/19/2021

Labeler - Rugby Laboratories (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0536-1053)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(0536-1053)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(0536-1053)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(0536-1053)