ADVANCED ASPIRIN- aspirin tablet

ADVANCED ASPIRIN by

Drug Labeling and Warnings

ADVANCED ASPIRIN by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG

PURPOSE

PAIN RELIEVER/FEVER REDUCER

INDICATIONS & USAGE

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

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

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients:

microcrystalline cellulose,

povidone, pregelatinized starch

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (SNOW WHITE)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FR21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-232-68	100 in 1 CARTON	04/07/2015
1	NDC: 67060-232-02	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/07/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-232)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-232)