ASPIRIN LOW DOSE CHEWABLE- aspirin tablet, chewable 
Time-Cap Labs, Inc

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Aspirin 81 mg Low Dose Chewable Tablets Orange Flavor

ACTIVE INGREDIENTS

Active ingredient (in each tablet) Purpose

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever

*nonsteroidal anti-inflammatory drug




Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor

• ask your doctor about other uses for 81 mg orange chewable aspirin

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a 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

  • 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

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
ringing in the ears or a 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 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.

Other information

Directions

Inactive ingredients butylated hydroxytoluene, dextrates, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, modified corn starch, pregelatinized starch, sodium saccharin, stearic acid

Questions or comments? Call 1-877-290-4008

aspirin-orange-36-labelaspirin-orange-108s-ifc

ASPIRIN  LOW DOSE CHEWABLE
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-334
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DEXTRATES (UNII: G263MI44RU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
ORANGE (UNII: 5EVU04N5QU)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code UPPER;tcl334;LOWER;PLAIN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-334-6336 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
2NDC:49483-334-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
3NDC:49483-334-193 in 1 CARTON04/19/2024
336 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/16/2010
Labeler - Time-Cap Labs, Inc (037052099)
Registrant - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture(49483-334)

Revised: 4/2024
Document Id: 16498b52-a996-8c49-e063-6294a90a1253
Set id: 5d56618c-8ea2-42ea-a9f2-339bd0055ddd
Version: 4
Effective Time: 20240417
 
Time-Cap Labs, Inc