NDC | 70518-0838-0, 70518-0838-1 |
Set ID | f789d28d-6087-453a-b85e-ef0aad5a033d |
Category | HUMAN OTC DRUG LABEL |
Packager | REMEDYREPACK INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredient (in each tablet)
- Purpose
- Uses
- for the temporary relief of minor aches and pains
- ask your doctor about other uses for aspirin
- 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
- asthma (wheezing)
- shock
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
Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
- you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma
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
- taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,
ask a health professional before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.
- Directions
- drink a full glass of water with each dose
- swallow whole, do not chew or crush
- do not exceed recommended dose
- adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum
Close
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 - PRINCIPAL DISPLAY PANEL
DRUG: Adult Low Dose Enteric Coated Aspirin
GENERIC: Aspirin
DOSAGE: TABLET, DELAYED RELEASE
ADMINSTRATION: ORAL
NDC: 70518-0838-0
NDC: 70518-0838-1
COLOR: yellow
SHAPE: ROUND
SCORE: No score
SIZE: 7 mm
IMPRINT: T81
PACKAGING: 30 in 1 BOTTLE, PLASTIC
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- ASPIRIN 81mg in 1
INACTIVE INGREDIENT(S):
- ANHYDROUS LACTOSE
- DIMETHICONE
- SHELLAC
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
- BROWN IRON OXIDE
- CELLULOSE, MICROCRYSTALLINE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- HYPROMELLOSES
- POTASSIUM HYDROXIDE
- POLYSORBATE 80
- CROSCARMELLOSE SODIUM
- SODIUM HYDROXIDE
- D&C YELLOW NO. 10
- MINERAL OIL
- SILICON DIOXIDE
- FERROSOFERRIC OXIDE
- STARCH, CORN
- INGREDIENTS AND APPEARANCE
ADULT LOW DOSE ENTERIC COATED ASPIRIN
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0838(NDC:57896-985) 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SODIUM HYDROXIDE (UNII: 55X04QC32I) MINERAL OIL (UNII: T5L8T28FGP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) BROWN IRON OXIDE (UNII: 1N032N7MFO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:70518-0838-0 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 2 NDC:70518-0838-1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 11/13/2017 Labeler - REMEDYREPACK INC. (829572556)