Label: ASPIR LOW- aspirin tablet
- NDC Code(s): 66267-028-00, 66267-028-30, 66267-028-90, 66267-028-91
- Packager: NuCare Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-7704
- 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.
Updated January 22, 2020
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- Active ingredient
- Keep Out of Reach of Children
Reyeʼs syndrome: Children and teenagers who have or are recovering from chicken pox or flulike
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
Do not use ■ if you are allergic to aspirin or any other pain reliever/fever reducer
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
■ under a doctor’s care for any serious condition ■ taking any other drug
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
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.
- Inactive ingredients
■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
■ use by expiration date on package
**Compare to the active ingredient in BAYER® Low Dose
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered
trademark Bayer® Low Dose.
31778 Enterprise Drive,
Livonia, MI 48150 USA
LOW STRENGTH 81mg ASPIRIN (NSAID)
1 1/4 gr. (81 mg) each Analgesic
SEE NEWWARNINGS INFORMATION
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66267-028(NDC:0904-7704) 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) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) STARCH, CORN (UNII: O8232NY3SJ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) 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 Size 7mm Flavor Imprint Code HEART Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66267-028-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2016 2 NDC:66267-028-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2016 3 NDC:66267-028-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2016 4 NDC:66267-028-91 120 in 1 BOTTLE; Type 0: Not a Combination Product 09/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 05/24/2011 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(66267-028)