NDC | 49483-381-10, 49483-381-12 |
Set ID | 9cb0c2df-5e72-42c5-ae93-144201fd263c |
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, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, d&C yellow #10 aluminum lake,hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, Polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, 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:49483-381 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) TALC (UNII: 7SEV7J4R1U) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) SODIUM HYDROXIDE (UNII: 55X04QC32I) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BROWN IRON OXIDE (UNII: 1N032N7MFO) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code T81 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-381-12 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2018 2 NDC:49483-381-10 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 08/10/2010 Labeler - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-381)