Label: DIRECT SAFETY ASPIRIN- aspirin tablet, coated
DIRECT SAFETY ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 61245-616-13, 61245-620-13
- Packager: Direct Safety
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
If an allergic reaction occurs, stop use and seek medical help right away.
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 alcohol drinks every day while using this product
■ take more or for a longer time than directed
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
■ an allergic reaction occurs. Seek medical help right away.
■ 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
■ pain gets worse or lasts more than 10 days
■ fever lasts more than 3 days
■ if ringing in the ears or loss of hearing occurs
■ redness or swelling is present
■ new symptoms occur
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIRECT SAFETY ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61245-620 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code FR21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61245-620-13 250 in 1 BOX 02/15/2021 04/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/15/2021 04/01/2024 DIRECT SAFETY ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61245-616 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;157;ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61245-616-13 250 in 1 BOX 02/15/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/15/2021 Labeler - Direct Safety (023316151) Registrant - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 pack(61245-616, 61245-620)