ZEE ASPIRIN- aspirin tablet Zee Medical 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. ---------- Drug Facts Active Ingredient/Tablet Aspirin 325 mg Purpose-Pain Reliever/Fever Reducer Temporarily relieves pain due to: headache, muscular aches, cold, minor pain of arthritis. Temporarily reduces 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 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
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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,
MM
1
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
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