Label: ASPIRIN DELAYED RELEASE- aspirin tablet, delayed release
- NDC Code(s): 49483-349-00
- Packager: Time-Cap Labs, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 December 14, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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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
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) 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
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- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
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STOP USE
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding
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- 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
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INACTIVE INGREDIENT
Inactive ingredients
anhydrous lactose, black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD-C red 40 aluminum lake, FD-C yellow 6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, triethyl citrate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN DELAYED RELEASE
aspirin tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-349 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg in 81 Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color orange (PEACH) Score no score Shape ROUND Size 7mm Flavor Imprint Code L277 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-349-00 100000 in 1 CARTON; Type 0: Not a Combination Product 12/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 12/23/2010 Labeler - Time-Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time-Cap Labs, Inc 037052099 manufacture(49483-349)