Label: ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55154-6755-0 - Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 66553-001
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated May 13, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Hospak® Unit Dose Products
- Active ingredient
- 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:
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- Hives
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- Facial swelling
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- Shock
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- Asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- Are age 60 or older
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- Have had stomach ulcers or bleeding problems
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- Take a blood thinning (anticoagulant) or steroid drug
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- Have 3 or more alcoholic drinks every day while using this product
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- Take more or for a longer time than directed
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- Take other drugs containing prescription or nonprescription NSAIDS (aspirin, ibuprofen, naproxen, or others)
Do not use - if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
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- Stomach bleeding warning applies to you
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- You have a history of stomach problems, such as heartburn
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- You have asthma
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- You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- You are taking a diuretic
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- You have not been drinking fluids
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- You have lost a lot of fluid due to vomiting or diarrhea
Ask a doctor or pharmacist before use if you are
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- Taking a prescription drug for diabetes, gout or arthritis
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- Taking any other drug
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- Under a doctor’s care for any serious condition
Warning:
This Unit Dose package is not child resistant and is Intended for Institutional Use Only.
Stop use and ask a doctor if
-you experience any of the following signs of stomach bleeding
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- Feel faint
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- Have bloody or black stools
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- Vomit blood
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- have stomach pain that does not get better
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- pain get worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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- ringing in the ears or 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.
- DirectionsDrink a full glass of water with each doseAdults and children 12 years and over:Take 1 to 2 tablets every 4 hours while symptoms last.Do not take more than 12 tablets in 24 hours unless directed by a doctorChildren under 12 years: consult a doctor
- Keep Out of Reach of Children
- Inactive ingredients
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Other Information
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- Do not use if packet is torn, cut or opened.
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- Store at 25C (77F) excursions permitted between 15-30C (59-86F)
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- use by expiration date on package
Mfg. by: Time-Cap Labs Inc., Farmingdale, NY 11735
Dist. By: Hospak® Unit Dose Products, Huntley, IL 60142
Rev. 08/17
Distributed by:
Cardinal HealthDublin, OH 43017
L42652450218A
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-6755(NDC:66553-001) 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-6755-0 10 in 1 BAG 06/02/2011 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/02/2011 Labeler - Cardinal Health (603638201)
