CAREALL ASPIRIN- aspirin tablet, chewable

CAREALL Aspirin by

Drug Labeling and Warnings

CAREALL Aspirin by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Uses

Temporary relief of minor aches and pains or as recommended by your doctor.  To reduce fever.

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 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.

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, flavor, saccharin sodium

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ASPIRIN 
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	03/29/2016

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)