SUNMARK ASPIRIN ADULT LOW STRENGTH- aspirin tablet, chewable 
Central Texas Community Health Centers

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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McKesson Aspirin Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains

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 have ever had an allergic reaction to any pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 have asthma
  • you are taking a diuretic

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
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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 right away. (1-800-222-1222)

Directions

Do not exceed 48 tablets in 24 hours or as directed by a doctor.

Other information

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow #6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-800-719-9260

PRINCIPAL DISPLAY PANEL - 81 mg Bottle Carton Label

CommUnityCare Federally Qualified Health Centers

ASPIRIN
81mg
CHEWABLE
TABS #36

Date:

Name:
Dr.

TAKE AS DIRECTED.

123456

1/1/01

ASPIRIN 81mg #36 CHEWABLE TABS NDC 76413-330-36

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel - 81 mg Bottle Carton Label
SUNMARK ASPIRIN  ADULT LOW STRENGTH
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-330(NDC:49348-498)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorORANGE (Light Orange) Scoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code L467
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-330-361 in 1 CARTON09/19/2003
136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/19/2003
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-330) , RELABEL(76413-330)

Revised: 12/2016
Document Id: 7af113ee-f653-452e-a74a-b9d0ed27e6af
Set id: 1424014a-0e3d-47ac-9c3a-e15b58eff038
Version: 1
Effective Time: 20161213
 
Central Texas Community Health Centers