CAREALL ASPIRIN- aspirin tablet, chewable 
New World Imports, Inc

----------

Drug Facts

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever 

Keep out of reach of children.

In case of accidental overdose, get medical help or contact aPoison Control Center (1-800-222-1222) right away

Uses

for the temporary relief of minor aches and paines or as recommended by your doctor

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 NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

-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)

-Take more or for a longer time than directed

-Are age 60 or older

-Have 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

-If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if:

-Stomach bleeding warning applies to user

-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 of pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis.

Stop use and ask a doctor if:

-You experience any of the following signs of stomach bleeding: feel faint, vomit blood, has bloody or black stool, 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.

Directions

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 doctor

Inactive Ingredients

corn starch, dextrates, FD C yellow 6 aluminum lake, orange flavor, saccharin sodium

CCA36 Label
CAREALL ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin81 mg
Inactive Ingredients
Ingredient NameStrength
Dextrates (UNII: G263MI44RU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Starch, Corn (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colororange (Pale Orange) Scoreno score
ShapeROUND (Round) Size8mm
FlavorImprint Code AZ;013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-057-3636 in 1 BOTTLE; Type 0: Not a Combination Product03/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/29/2016
Labeler - New World Imports, Inc (075372276)

Revised: 12/2023
Document Id: 91fa8291-db07-44be-afbf-c69f08f00426
Set id: f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac
Version: 3
Effective Time: 20231206
 
New World Imports, Inc