Label: CARDIASPIRIN PROTECT- aspirin tablet, coated
- NDC Code(s): 69729-104-12
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated August 21, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- 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 or pharmacist 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 a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be sing 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, Microcrystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
- Questions or comments?
- Cardiaspirin Protect Label
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INGREDIENTS AND APPEARANCE
CARDIASPIRIN PROTECT
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-104 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) BROWN IRON OXIDE (UNII: 1N032N7MFO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) TALC (UNII: 7SEV7J4R1U) METHACRYLIC ACID (UNII: 1CS02G8656) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-104-12 1 in 1 CARTON 08/21/2023 1 120 in 1 BOTTLE, PLASTIC; 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 08/21/2023 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations Health Pharma USA LLC 080804485 label(69729-104) , manufacture(69729-104) , pack(69729-104)