ASPIRIN- aspirin tablet 
Rugby Laboratories Inc.

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.

----------

Aspirin Tablets (NSAID)
* nonsteroidal anti-inflammatory drug

Active Ingredient

(in each tablet)

Aspirin 81 mg

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.

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 signs 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 chances 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 non-prescription NSAIDs (ibuprofen, naproxen, or others)
take more or for longer time than directed
have 3 or more alcoholic drinks every day while using this product
 
Do not use if you have ever had an allergic reaction to any other pain reliever / fever reducer
 
Ask a doctor before use if
stomach bleeding warning applies to you
you have 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 diabetes, gout or arthritis
under a doctor’s care for any serious condition
taking any other drug
 
Stop use and ask a doctor if
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
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any symptoms appear
ringing in the ears or loss of hearing occurs
 
If pregnant or breast feeding,  ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complication 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 & older: take 4 or 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
children under 12 years: ask a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, D&C Yellow # 10 (AL-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol/propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Questions or Comments

Call 1-800-645-2158, 9am–5pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 0536-3086-41

Rugby

Enteric Coated

Aspirin 81 mg Tablets (NSAID)

Analgesic

120 Tablets

bottle label

Principal Display Panel

NDC 0536-3086-10

Rugby

Enteric Coated

Aspirin 81 mg Tablets (NSAID)
Analgesic

1000 Tablets

bottle label
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3086-41120 in 1 BOTTLE; Type 0: Not a Combination Product04/28/200807/29/2018
2NDC:0536-3086-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/28/200812/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/28/200812/31/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
 
Rugby Laboratories Inc.