ASPIRIN- aspirin tablet 
Safetec of America, Inc.

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 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

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:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

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
    • redness or swelling is present
    • fever lasts more than 3 days
    • 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 right away.

Directions

Other information

Inactive ingredients

corn starch, povidone

Questions or comments?

Call toll free: 1-800-456-7077

Principal Display Panel - 325 mg Pouch Label

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Aspirin Pain Reliever/Fever Reducer

ORIGINAL STRENGTH

2 Tablets

Principal Display Panel - 325 mg Pouch Label

Principal Display Panel – 50 Count Carton Label

Safetec®
of America, Inc.

*Compare to the active ingredient in
Bayer Genuine Aspirin®

NDC 61010-4407-1

ORIGINAL STRENGTH

Aspirin

Aspirin 325 mg Pain Reliever/Fever Reducer

PUSH TO OPEN

Dispense
through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per Pouch

Principal Display Panel – 50 Count Carton Label

Principal Display Panel – 100 Count Carton Label

Safetec®
of America, Inc.

*Compare to the active ingredient in
Bayer Genuine Aspirin®

NDC 61010-4407-2

ORIGINAL STRENGTH

Aspirin

Aspirin 325 mg – Pain Reliever/Fever Reducer

PUSH TO OPEN

Dispense
through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per Pouch

Principal Display Panel – 100 Count Carton Label
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4407
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg
Inactive Ingredients
Ingredient NameStrength
starch, corn (UNII: O8232NY3SJ)  
povidone (UNII: FZ989GH94E)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ASPIRIN;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4407-02 in 1 POUCH; Type 0: Not a Combination Product12/30/2019
2NDC:61010-4407-150 in 1 BOX12/30/2019
2NDC:61010-4407-02 in 1 POUCH; Type 0: Not a Combination Product
3NDC:61010-4407-2100 in 1 BOX12/30/2019
3NDC:61010-4407-02 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/30/2019
Labeler - Safetec of America, Inc. (874965262)

Revised: 12/2019
Document Id: adc3c9bf-3c0e-4502-abd9-2e93433a2f67
Set id: 563820a8-c90c-45f2-8af4-a457bb094546
Version: 2
Effective Time: 20191230
 
Safetec of America, Inc.