CHEWABLE ASPIRIN LOW DOSE- chewable aspirin 81mg tablet, chewable 
Ulai Health LLC

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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Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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 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 get worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or 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 right away (1-800-222-1222).

Directions

 adults and children 12 years and over take 4 to 8 tablets every 4 hours not exceed 48 tablets in 24 hours unless directed by a doctor
 children under 12 years ask a doctor

Other information

Inactive ingredients

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PHARBEST

NDC 73057-366-11

Manufactured in the USA

ASPIRIN REGIMEN

Chewable 

Aspirin

Low Dose

81mg Pain Reliever (NSAID)

*Comapre to the active ingredient in BAYER® Chewable Aspirin

Orange Flavored

1000 TABLETS

Talk to your doctor or other healthcare provider before using this product for your heart.

Chewable Aspirin 81 mg Tablet Product Label

CHEWABLE ASPIRIN LOW DOSE 
chewable aspirin 81mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-366
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code PH034
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73057-366-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2019
2NDC:73057-366-0536 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34306/28/2019
Labeler - Ulai Health LLC (081181535)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Revised: 7/2019
Document Id: 23e3d899-2be1-48c4-adc8-b7584ceb1e69
Set id: 47095d07-183e-4984-95df-ccca1fa8b52a
Version: 1
Effective Time: 20190722
 
Ulai Health LLC