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Aspirin by RUGBY LABORATORIES, INC

Medically reviewed on Jan 15, 2018

Dosage form: tablet, coated
Ingredients: aspirin 81mg
Labeler: RUGBY LABORATORIES, INC
NDC Code: 0536-1004

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.

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.

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (aspirin) aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
BROWN IRON OXIDE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Codeheart
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1004-41120 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:0536-1004-101000 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/14/2014
Labeler - RUGBY LABORATORIES, INC (191427277)
Registrant - TIME CAP LABS, INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABS, INC037052099manufacture(0536-1004)

 
RUGBY LABORATORIES, INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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