Label: ASPIRIN EC- aspirin tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-684-00, 21695-684-30, 21695-684-72, 21695-684-90 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0182-1061
- 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 February 9, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- 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
- 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
- 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 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 a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug
- under a doctor's care for any serious condition
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
- Directions
- Other information
- Inactive ingredients
- Questions?
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SPL UNCLASSIFIED SECTION
Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960
Dist. 1993 0810REV 89 387R
Repackaged by: REBEL DISTRIBUTORS CORP, Thousand Oaks, CA 91320
TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose.
- PRINCIPAL DISPLAY PANEL - 81 mg Bottle Label
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INGREDIENTS AND APPEARANCE
ASPIRIN EC
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-684(NDC:0182-1061) 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) carnauba wax (UNII: R12CBM0EIZ) silicon dioxide (UNII: ETJ7Z6XBU4) croscarmellose sodium (UNII: M28OL1HH48) D&C Yellow NO. 10 (UNII: 35SW5USQ3G) aluminum oxide (UNII: LMI26O6933) cellulose, microcrystalline (UNII: OP1R32D61U) polysorbate 80 (UNII: 6OZP39ZG8H) sodium hydroxide (UNII: 55X04QC32I) sodium lauryl sulfate (UNII: 368GB5141J) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) triethyl citrate (UNII: 8Z96QXD6UM) Product Characteristics Color YELLOW Score no score Shape ROUND (Bi-convex) Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-684-30 30 in 1 BOTTLE 2 NDC:21695-684-90 90 in 1 BOTTLE 3 NDC:21695-684-00 100 in 1 BOTTLE 4 NDC:21695-684-72 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 01/01/1993 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK
