NDC | 69517-104-01, 69517-104-02, 69517-104-25, 69517-104-30, 69517-104-50, 69517-104-60, 69517-104-65 |
Set ID | f0ce670a-179a-462c-ad4f-02129c456ffb |
Category | HUMAN OTC DRUG LABEL |
Packager | HealthLife Of USA |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
- shock
- facial swelling
- asthma (wheezing)
Stomach bleeding warning
- This product contains an NSAID, 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 containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Ask a doctor before use if
- you have asthma
- 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
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- under a doctor's care for any serious condition
- taking any other drug
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs.
Seek medical help right away.
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling present in the painful area
- new symptoms occur
These could be sign of a serious condition
- Directions
- Other information
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Inactive ingredients
Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
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Questions or comments?
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER
aspirin 81 mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) BROWN IRON OXIDE (UNII: 1N032N7MFO) METHACRYLIC ACID (UNII: 1CS02G8656) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-104-25 25 in 1 BOX 06/05/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:69517-104-50 50 in 1 BOX 06/05/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:69517-104-02 2 in 1 POUCH 06/05/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:69517-104-01 1000 in 1 BOTTLE 06/05/2017 4 NDC:69517-104-65 365 in 1 BOTTLE 4 NDC:69517-104-30 30 in 1 BOTTLE 4 1 in 1 CARTON; Type 0: Not a Combination Product 5 NDC:69517-104-60 1 in 1 CARTON 06/05/2017 5 60 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 02/09/2016 Labeler - HealthLife Of USA (079656178) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceutical Ltd. 915664486 manufacture(69517-104)