ADVANCED ASPIRIN- aspirin tablet 
ADVANCED FIRST AID, 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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ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG

PAIN RELIEVER/FEVER REDUCER

Uses:

temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis•

muscle pain • pain and fever of colds • toothache • temporarily reduces fever

Uses:

temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis

muscle pain • pain and fever of colds • toothache • 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

Stomach Bleeding Warning:

This product contains nonsteroidal anti-inflammatory drugs (NSAIDs),

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 prescription or nonprescription containing an NSAID [aspirin, ibuprofen, naproxen, or

others]

• 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 a sodium-restricted diet

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:

• you feel faint, vomit blood, or have bloody

or black stools

• redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts

more than 3 days

• new symptoms occur • ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding baby,

ask a health professional

before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS

SPECIFIC-ALLY 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. Prompt medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Drink a full glass of water with each dose

Adults and children 12 years OR OLDER :TAKE 2 TABLETS EVERY 4-6 HOURS AS needed, do not exceed 12 tablets in

24 hours, or as directed by a doctor.

Children under 12 YEARSOF AGE

• consult a doctor

Inactive Ingredients:

microcrystalline cellulose,

povidone, pregelatinized starch

ASPIRIN CARTON

image description

ADVANCED ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-232
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-232-68100 in 1 CARTON04/07/2015
1NDC:67060-232-022 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/07/2015
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-232)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-232)

Revised: 4/2015
Document Id: 627cbe02-0c2e-41ef-a26f-6fb7dce0c13f
Set id: 7369cf7e-b1b8-4faf-982c-454e2ae6cbfa
Version: 1
Effective Time: 20150407
 
ADVANCED FIRST AID, INC.