ZEE ASPIRIN- aspirin tablet Zee Medical IncDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug FactsActive Ingredient/Tablet Aspirin 325 mg

Purpose-Pain Reliever/Fever Reducer

Temporarily relieves pain due to: headache, muscular aches, cold, minor pain of arthritis. Temporarilyreduces fever

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

Children under 12 years, ask a doctor

Warnings: Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flusymptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to beassociated 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 us ing 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 pharmacis t 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

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

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 Ingredients: corn starch, microcrystalline cellulose, povidone,

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ZEE ASPIRIN aspirin tablet

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:35418 -232

Route of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E) ASPIRIN 325 mg

Inactive IngredientsIngredient Name Strength

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

PO VIDO NE K2 9 /3 2 (UNII: 39 0 RMW2PEQ)

Product CharacteristicsColor white (sno w white) Score no sco re

Shape ROUND ( FR21) Siz e 10 mm

Flavor Imprint Code FR21

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:35418 -232-6 8 50 in 1 CARTON 0 6 /12/20 12

1 NDC:35418 -232-6 7 125 in 1 CARTON

1 NDC:35418 -232-0 2 2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2 NDC:35418 -232-70 24 in 1 BOX 0 6 /12/20 12

2 NDC:35418 -232-6 7 125 in 1 CARTON

Zee Medical Inc

2 NDC:35418 -232-0 2 2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part343 0 6 /12/20 12

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Ultra tab Labo ra to ries, Inc . 1510 51757 manufacture(35418 -232)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Ultra Seal Co rpo ra tio n 0 8 57520 0 4 repack(35418 -232)

Revised: 10/2019