Label: CAREALL ASPIRIN- aspirin tablet, chewable
- NDC Code(s): 51824-057-36
- Packager: New World Imports, 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.
Updated March 29, 2016
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- Active Ingredient
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drugClose
Pain reliever / fever reducerClose
- Keep out of reach of children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately.Close
Temporary relief of minor aches and pains or as recommended by your doctor. To reduce fever.Close
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 NSAID, which may cause severe stomach bleeding. The chance is higher if the user:
-Has had stomach ulcers or bleeding problems
-Takes a blood thinning (anticoagulant) or steroid drug
-Takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
-Takes more or for a longer time than directed
-Is age 60 or older
-Has 3 or more alcoholic drinks every day while using this product
Do not use: if you are allergic to aspirin or other pain relievers / fever reducers. For at least 7 days after tonsillectomy or oral surgery unless directed by a doctor.
Ask a doctor before use if:
-Stomach bleeding warning applies to user
-user has history of stomach problems, such as heartburn
-User has high blood pressure, heart disease, liver cirrhosis, or kidney disease
-User is taking a diuretic
-You have asthma
Ask a doctor of pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis.
Stop use and ask a doctor if:
-User 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
-An allergic reaction occurs. Seek medical help help right away
-New symptoms occur
-Redness or swelling is present
-Pain gets worse or lasts for more than 10 days
-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 unborn child or complications during delivery.Close
Drink a full glass of water with each dose.
Adults and children 12 years and over: take 4 to 8 tablets every 4 hours. Not to exceed 48 tablets in 24 hours unless directed by a doctor.
Children under 12: consult a doctorClose
- Inactive Ingredients
corn starch, dextrates, FD C yellow 6, flavor, saccharin sodiumClose
- INGREDIENTS AND APPEARANCE
aspirin tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-057 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) Saccharin Sodium (UNII: SB8ZUX40TY) Starch, Corn (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange (Pale Orange) Score no score Shape ROUND (Round) Size 8mm Flavor Imprint Code AZ;013 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-057-36 36 in 1 BOTTLE; 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 03/29/2016 Labeler - New World Imports, Inc (075372276)