ASPIRIN- aspirin tablet 
Certified Safety Manufacturing

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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Aspirin

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID1) 325 mg


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with

Temporarily reduces fever.

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

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • if you are taking prescription drugs for gout, diabetes or arthritis

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

  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • 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
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful area
  • any new symptoms appear

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

Adults and children:
(12 years and older)
Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.
Children under 12 years:Do not give to children under 12 years of age.

Other information

Inactive ingredients

corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Questions or comments?

1-800-xxx-xxxx

PRINCIPAL DISPLAY PANEL - 25 Pouch Box

Tamper evident
packaging:
Do not use if
open or torn.

This package for
households
without children

See New Warnings
Information

Compare to Bayer®

CERTI-ASPIRIN™

325 mg Aspirin (NSAID)*

PRINCIPAL DISPLAY PANEL - 25 Pouch Box
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48083-654
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg
Inactive Ingredients
Ingredient NameStrength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Mineral Oil (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Propylene Glycol (UNII: 6DC9Q167V3)  
STARCH, CORN (UNII: O8232NY3SJ)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL;011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48083-654-6624 in 1 BOX12/29/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:48083-654-2725 in 1 BOX12/29/2017
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:48083-654-3050 in 1 BOX12/29/2017
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:48083-654-33125 in 1 BOX12/29/2017
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:48083-654-36250 in 1 BOX12/29/2017
52 in 1 POUCH; Type 0: Not a Combination Product
6NDC:48083-654-39500 in 1 BOX12/29/2017
62 in 1 POUCH; Type 0: Not a Combination Product
7NDC:48083-654-411000 in 1 BOX12/29/2017
72 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34312/29/2017
Labeler - Certified Safety Manufacturing (788460483)

Revised: 12/2017
Document Id: 3b31c63f-365c-4321-9a1c-e316c218c6d0
Set id: 0accb885-33d3-4c51-9f71-fa2ac4d22245
Version: 1
Effective Time: 20171215
 
Certified Safety Manufacturing