Label: ASPIRIN LOW DOSE- aspirin tablet, coated
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NDC Code(s):
71335-0622-1,
71335-0622-2,
71335-0622-3,
71335-0622-4, view more71335-0622-5, 71335-0622-6, 71335-0622-7, 71335-0622-8, 71335-0622-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 57896-981
- 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 March 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- 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 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
These can be signs of a serious condition.
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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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HOW SUPPLIED
NDC: 71335-0622-8: 15 Tablets in a BOTTLE
NDC: 71335-0622-1: 120 Tablets in a BOTTLE
NDC: 71335-0622-2: 30 Tablets in a BOTTLE
NDC: 71335-0622-3: 100 Tablets in a BOTTLE
NDC: 71335-0622-4: 20 Tablets in a BOTTLE
NDC: 71335-0622-5: 90 Tablets in a BOTTLE
NDC: 71335-0622-6: 60 Tablets in a BOTTLE
NDC: 71335-0622-7: 36 Tablets in a BOTTLE
NDC: 71335-0622-9: 10 Tablets in a BOTTLE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN LOW DOSE
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-0622(NDC:57896-981) 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 STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SHELLAC (UNII: 46N107B71O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0622-8 15 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2022 2 NDC:71335-0622-1 120 in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2018 3 NDC:71335-0622-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2018 4 NDC:71335-0622-3 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/11/2018 5 NDC:71335-0622-4 20 in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 6 NDC:71335-0622-5 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2018 7 NDC:71335-0622-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/22/2018 8 NDC:71335-0622-7 36 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2018 9 NDC:71335-0622-9 10 in 1 BOTTLE; Type 0: Not a Combination Product 02/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 07/01/2000 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0622) , RELABEL(71335-0622)