Label: ASPIRIN tablet, chewable
- NDC Code(s): 54738-128-36
- Packager: Richmond Pharmaceuticals, 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 October 30, 2017
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- Active Ingredient
- Purpose
- Use
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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 signs of Reye’s syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include
- hives
- asthma (wheezing)
- shock
- facial swelling
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child
- has had stomach ulcers or bleeding problems
- take a blood-thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
- takes more or for a longer time than directed
Do not use
- if the child has ever had an allergic reaction to any other pain reliever / fever reducer
- for at least 7 days after tonsillectomy or oral surgery
Ask a doctor before use if
- stomach bleeding warning applies to your child
- child has a history of stomach problems, such as heartburn
- child has not been drinking fluids
- child has lost a lot of fluid due to vomiting and diarrhea
- child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
- child is taking a diuretic
- child has asthma
Ask a doctor or pharmacist before use if the child is
- taking a prescription drug for diabetes, gout or arthritis
- taking any other drug
- under a doctor’s care for any serious condition
Stop use and ask a doctor if
- child experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- pain gets worse or lasts more than 5 days
- any new symptoms appear
- redness or swelling is present in the painful area
- ringing in the ears or a 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.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-128 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) ORANGE (UNII: 5EVU04N5QU) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) Product Characteristics Color orange Score no score Shape ROUND Size 8mm Flavor ORANGE Imprint Code AP;009 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-128-36 36 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 04/01/2015 Labeler - Richmond Pharmaceuticals, Inc. (043569607) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-128)
