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

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DRUG FACTS

Active Ingredient

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Keep out of Reach of Children

Keep out of reach of Children.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

For the temporary relief of minor aches and pain or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 included

Stomach Bleeding Warning: this product containers an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Do not use if you are allergic to aspirin or any other pain reliever / fever reducer

Ask a doctor before use if:

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

Stop use and ask a doctor if:

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

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 years of age: consult a doctor

Inactive Ingredients

colloidal silicon dioxide, corn starch, crospovidone, D C yellow 10 aluminum lake, FD C yellow 6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl ceitrate

ASP81120 Label

CAREALL ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Triethyl Citrate (UNII: 8Z96QXD6UM)  
talc (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeROUND (round convex) Size7mm
FlavorImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-077-01120 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/01/2020
Labeler - New World Imports, Inc (075372276)

Revised: 11/2023
Document Id: 1661f7e6-98ad-4ce3-b856-874d08116ec5
Set id: 58a371d4-1f00-4fda-8e08-80610c58505a
Version: 6
Effective Time: 20231121
 
New World Imports, Inc