ASPIRIN by RUGBY / TIME CAP LABORATORIES, INC RUGBY 387R ASA 81 MG

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by RUGBY, TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASPIRIN- aspirin tablet, coated 
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.

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RUGBY 387R ASA 81 MG

ACTIVE INGREDIENTS

EACH TABLET CONTAINS; ASPIRIN 81 MG (nsaid)* NON STEROIDAL ANTI-INFLAMMATORY DRUG

Inactive Ingredients

anhydrous lactose, carnauba wax, collodidal silicon dioxide, croscarmellose sodium, d&c yellow #10 aluminumlake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, tatanim dioxide, triethyl citrate

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, consul a doctor

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 becausse serious side effects may occur.

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-lie symptoms should not use this product.  When using this product, if changes in behaviour 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, facial swelling, shock, 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.

Pain Reliever

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

RUGBYLABEL1004

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code heart
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-1004-41120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/201401/01/2018
2NDC: 0536-1004-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/201401/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/14/201401/01/2018
Labeler - RUGBY LABORATORIES, INC (079246066)
Registrant - TIME CAP LABS, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS, INC037052099manufacture(0536-1004)

Revised: 11/2019
 
RUGBY LABORATORIES, INC