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aspirin low dose chewable by Time-Cap Labs, Inc

Dosage form: tablet, chewable
Ingredients: aspirin 81mg
Labeler: Time-Cap Labs, Inc
NDC Code: 49483-334

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.

DRUG FACTS

ACTIVE INGREDIENTS

Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug


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

Inactive ingredients: bht, dextrates, FD-C yellow #6 aluminum Lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid

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

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, consult a doctor

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 serous Illinois. 

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, 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, tae more or for a longer time than directed..

ASPIRIN  LOW DOSE CHEWABLE
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-334
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (ASPIRIN) aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
DEXTRATES 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) 
ORANGE 
STARCH, CORN 
SACCHARIN SODIUM DIHYDRATE 
STEARIC ACID 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeUPPER;tcl334;LOWER;PLAIN
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-334-6336 TABLET, CHEWABLE (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-334-00100000 TABLET, CHEWABLE (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/16/2010
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs, Inc037052099manufacture

 
Time-Cap Labs, Inc

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Medically reviewed on May 21, 2018

Further information

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

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