Label: ASPIRIN tablet
- NDC Code(s): 61010-4407-0, 61010-4407-1, 61010-4407-2
- Packager: Safetec of America, 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 30, 2019
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)
- Purposes
- Uses
-
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
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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
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
- redness or swelling is present
- fever lasts more than 3 days
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel - 325 mg Pouch Label
-
Principal Display Panel – 50 Count Carton Label
Safetec®
of America, Inc.*Compare to the active ingredient in
Bayer Genuine Aspirin®NDC 61010-4407-1
ORIGINAL STRENGTH
Aspirin
Aspirin 325 mg Pain Reliever/Fever Reducer
PUSH TO OPEN
Dispense
through opening- Relieves minor aches and pains
- Fever reducer
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
50 Pouches 2 Tablets per Pouch
-
Principal Display Panel – 100 Count Carton Label
Safetec®
of America, Inc.*Compare to the active ingredient in
Bayer Genuine Aspirin®NDC 61010-4407-2
ORIGINAL STRENGTH
Aspirin
Aspirin 325 mg – Pain Reliever/Fever Reducer
- Relieves minor aches and pains
- Fever reducer
PUSH TO OPEN
Dispense
through openingTAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches 2 Tablets per Pouch
-
INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-4407 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 starch, corn (UNII: O8232NY3SJ) povidone (UNII: FZ989GH94E) Product Characteristics Color white (WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ASPIRIN;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-4407-0 2 in 1 POUCH; Type 0: Not a Combination Product 12/30/2019 2 NDC:61010-4407-1 50 in 1 BOX 12/30/2019 2 NDC:61010-4407-0 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:61010-4407-2 100 in 1 BOX 12/30/2019 3 NDC:61010-4407-0 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 12/30/2019 Labeler - Safetec of America, Inc. (874965262)
