CAREALL ASPIRIN- aspirin tablet, coated

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 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 immediately.

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 with may included hives, facial swelling, asthma (wheezing) and shock

Stomach Bleeding Warning: this product containers an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Are age 60 or older
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)
Have 3 or more alcoholic drinks every day while using this product
Take more or for a longer time than directed

Do not use:

If you are allergic to aspirin or any other pain relievers / fever reducers

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 you
You have a history of stomach problems, such as heartburn
You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
You have asthma
You have taken a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of the blood), diabetes, gout, arthritis

Stop use and ask a doctor if:
An allergic reaction occurs. Seek medical help right away
You experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
New symptoms occur
Redness or swelling is present
Ringing in the ears or loss of hearing occurs
Pain gets worse or lasts more than 10 days
You may report serious 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 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: consult a doctor

Inactive Ingredients

anhydrous lactose, carnauba wax, croscarmellose sodium, D C yellow 10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, silicon dioxide, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.  May contain starch

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-055
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
Anhydrous lactose (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Croscarmellose Sodium (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
Iron (UNII: E1UOL152H7)
Methacrylic Acid (UNII: 1CS02G8656)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Dimethicone (UNII: 92RU3N3Y1O)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Titanium Dioxide (UNII: 15FIX9V2JP)
Triethyl Citrate (UNII: 8Z96QXD6UM)
talc (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	yellow (yellow)	Score	no score
Shape	ROUND (round)	Size	8mm
Flavor		Imprint Code	A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-055-01	120 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	03/01/2016

Labeler - New World Imports, Inc (075372276)