Label: CHILDRENS ASPIRIN- aspirin tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 55154-6752-0 - Packager: Cardinal Health, Inc.
- This is a repackaged label.
- Source NDC Code(s): 66553-002
- 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 December 3, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Keep Out of Reach of Children
- 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 you are allergic to aspirin or any other pain reliever/fever reducer -this product for at least 7 days after tonsillectomy or oral surgery unless directed by doctor.
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 for more than 10 days ·redness or swelling is present ·new symptoms occur ·ringing in the ears or loss of hearing occurs ·You may report side effects to 1-888-952-0050.
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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Directions
- Inactive ingredients
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Storage
Store at room temperature. Do not use if packet is torn, cut or opened.
Questions? 1-847-458-5308
Mfg. by: Allegiant Health, Deer Park, NY 11729
Dist. By: Hospak® Unit Dose Products, Huntley, IL 60142
Hospak is a trademark owned by its respective owner.
Distributed By:
Cardinal Health
Dublin, OH 43017
L40737140818
Rev. 08/17
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHILDRENS ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-6752(NDC:66553-002) 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 DEXTRATES (UNII: G263MI44RU) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (Peach) Score no score Shape ROUND Size 7mm Flavor Imprint Code AZ;013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-6752-0 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, Inc. (603638201)