ZEE ASPIRIN- aspirin tablet

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient/Tablet Aspirin 325 mg
PURPOSE

Purpose-Pain Reliever/Fever Reducer
INDICATIONS & USAGE

Temporarily relieves pain due to: headache, muscular aches, cold, minor pain of arthritis. Temporarily reduces fever
DOSAGE & ADMINISTRATION

Adults: Take 2 tablets every 4hours, not to exceed 12 caplets in 24 hours

Children under 12 years, ask a doctor
WARNINGS

Warnings:
Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause 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 an NSAID (aspirin, ibuprofen, naproxen, or others.
    Take more or for a longer time than directed

Allergy Alert-Do not use:
    if you are allergic to aspirin or any other salicylates
    If you have ever had an allergic reaction to any other pain reliever/fever reducer

Do not use:
    with any other pain reliever/fever reducer

Ask doctor before using if you have:
    upset stomach or stomach pain
    ulcers
    bleeding problems
    high blood pressure
    heart or kidney disease
    taken a diuretic
    reached age 60 or older

Ask a doctor or pharmacist before use if you are:
    taking any other drug containing an NSAID (prescription or nonprescription)
    taking a blood thinning (anticoagulant) or steroid drug

Stop use and ask a doctor if:
    ringing in the ears or loss of hearing occurs
    pain or fever persists or gets worse
    new symptoms occur
    redness or swelling is present
    you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional
before use
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.
INACTIVE INGREDIENT

Inactive Ingredients: corn starch, microcrystalline cellulose,
povidone,
PRINCIPAL DISPLAY PANEL

MM

1

INGREDIENTS AND APPEARANCE

ZEE ASPIRIN
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-232
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K29/32 (UNII: 390RMW2PEQ)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 35418-232-68	50 in 1 CARTON	06/12/2012
1	NDC: 35418-232-67	125 in 1 CARTON
1	NDC: 35418-232-02	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 35418-232-70	24 in 1 BOX	06/12/2012
2	NDC: 35418-232-67	125 in 1 CARTON
2	NDC: 35418-232-02	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	06/12/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

Name	Address	ID/FEI	Business Operations
Establishment
Ultratab Laboratories, Inc.		151051757	manufacture(35418-232)

Name	Address	ID/FEI	Business Operations
Establishment
Ultra Seal Corporation		085752004	repack(35418-232)

ZEE ASPIRIN- aspirin tablet

Zee Aspirin by

Drug Labeling and Warnings

Drug Details [pdf]