ASPIRIN- aspirin tablet 
Genuine First Aid 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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ASPIRIN 325mg

Active Ingredient (in each tablet)

  Aspirin (NSAID *) 325 mg
*nonsteroidal anti-inflammatory drug 

Purpose

Pain Reliever / fever reducer 

Uses

Temporarily relieves minor aches and pains associated with:
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

Warnings

Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox of 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, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:   This 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 thinner (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 have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug 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

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

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; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important 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

do not use more than directed

the smallest effective dose should be used

drink a full glass of water with each dose

do not take longer than 10 days, unless directed by a doctor


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.

Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid

excessive heat and humidity;  tamper evident sealed packets;

Do not use any opened or torn packets

Inactive Ingredients

hypromellose, polyethylene glycol, propylene glycol, corn starch

Distributed by GENUINE FIRST AID
600 Clevelad Str Suite 400, Clearwater, FL 33755

Aspirin 325 mg
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;157;ASPIRIN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52124-0011-12 in 1 PACKAGE; Type 0: Not a Combination Product04/23/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/23/2010
Labeler - Genuine First Aid LLC (619609857)

Revised: 12/2017
Document Id: 61952fe1-815b-ff6e-e053-2a91aa0a2d58
Set id: b13ad410-729e-4e8e-b172-d751ee21a91a
Version: 13
Effective Time: 20171230
 
Genuine First Aid LLC