CAREALL ASPIRIN- aspirin tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E)
Available from:
New World Imports, Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain Reliever 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.
Authorization status:
OTC monograph final
Authorization number:
51824-055-01

CAREALL ASPIRIN- aspirin tablet, coated

New World Imports, Inc

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.

----------

DRUG FACTS

Active Ingredient

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpos e

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.

Us es

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

CAREALL ASPIRIN

aspirin tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:518 24-0 55

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aspirin (UNII: R16 CO5Y76 E) (Aspirin - UNII:R16 CO5Y76 E)

Aspirin

8 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Anhydro us la cto se (UNII: 3SY5LH9 PMK)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Cro sca rmello se So dium (UNII: M28 OL1HH48 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Iro n (UNII: E1UOL152H7)

Metha crylic Acid (UNII: 1CS0 2G8 6 56 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

Po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

Dimethico ne (UNII: 9 2RU3N3Y1O)

So dium Hydro xide (UNII: 55X0 4QC32I)

So dium La uryl Sulfa te (UNII: 36 8 GB5141J)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

Triethyl Citra te (UNII: 8 Z9 6 QXD6 UM)

ta lc (UNII: 7SEV7J4R1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

yello w (yello w)

S core

no sco re

S hap e

ROUND (ro und)

S iz e

8 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:518 24-0 55-0 1

120 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 1/20 16

Marketing Information

New World Imports, Inc

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt343

0 3/0 1/20 16

Labeler -

New World Imports, Inc (075372276)

Revised: 10/2018

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