NDC | 49483-328-01, 49483-328-10 |
Set ID | 55d645bb-8645-4984-a7b9-3e6eed8c6412 |
Category | HUMAN OTC DRUG LABEL |
Packager | Time-Cap Labs, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
ANHYDROUS LACTOSE, CARNAUBA WAX, COLLOIDAL SILICON DIOXIDE, CROSCARMELLOSE SODIUM, FD&C YELLOW#6 ALUMINUM LAKE, FD&C RED #40 ALUMINUM LAKE, IRON OXIDE OCHRE, METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, SIMETHICONE, SODIUM HYDROXIDE, SODIUM LAURYL SULFATE, TALC, TRIETHYL CITRATE - PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- facial swelling
- shock
- 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
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- DO NOT USE
-
ASK DOCTOR
Ask a doctor before use if
- 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
- you have asthma
- you have not been drinking fluids
- you have lost a lot of fluid due to vomiting or diarrhea
- ASK DOCTOR/PHARMACIST
-
STOP USE
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LOW DOSE ASPIRIN ENTERIC SAFETY COATED
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-328 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) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color white (ENTERIC COATED PEACH) Score no score Shape ROUND Size 7mm Flavor Imprint Code emobssed;upper;heart;lower;plain Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-328-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 2 NDC:49483-328-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 08/11/2010 Labeler - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-328)