Label: ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 48083-654-27, 48083-654-30, 48083-654-33, 48083-654-36, view more48083-654-39, 48083-654-41, 48083-654-66 - Packager: Certified Safety Manufacturing
- 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 15, 2017
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 (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
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
- if you have ever had an allergic reaction to any other pain reliever/ fever reducer
- if you are taking prescription drugs for gout, diabetes or arthritis
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
- 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
- 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 gets worse or lasts more than 3 days
- if ringing in the ears or loss of hearing occurs
- redness or swelling is present in the painful area
- any new symptoms appear
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Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
- drink a full glass of water with each dose
Adults and children:
(12 years and older)Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children under 12 years of age. - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 25 Pouch Box
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48083-654 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 POWDERED CELLULOSE (UNII: SMD1X3XO9M) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Microcrystalline Cellulose (UNII: OP1R32D61U) Mineral Oil (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Propylene Glycol (UNII: 6DC9Q167V3) STARCH, CORN (UNII: O8232NY3SJ) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code TCL;011 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48083-654-66 24 in 1 BOX 12/29/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:48083-654-27 25 in 1 BOX 12/29/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:48083-654-30 50 in 1 BOX 12/29/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:48083-654-33 125 in 1 BOX 12/29/2017 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:48083-654-36 250 in 1 BOX 12/29/2017 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:48083-654-39 500 in 1 BOX 12/29/2017 6 2 in 1 POUCH; Type 0: Not a Combination Product 7 NDC:48083-654-41 1000 in 1 BOX 12/29/2017 7 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 12/29/2017 Labeler - Certified Safety Manufacturing (788460483)