CHRONIC PAIN/FEVER RELIEF

Main information

  • Trade name:
  • CHRONIC PAIN/FEVER RELIEF- aspirin delayed release tablets, 81 mg tablet
  • Composition:
  • Aspirin 81 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHRONIC PAIN/FEVER RELIEF- aspirin delayed release tablets, 81 mg tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • - for the temporary relief of minor aches and pains 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. - ask your doctor about other uses for 81 mg Aspirin

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 70005-002-02, 70005-002-25, 70005-002-50
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CHRONIC PAIN/FEVER RELIEF- aspirin delayed release tablets, 81 mg tablet

We Care Distributor 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.

----------

Chronic Pain/Fever Relief - Aspirin Delayed Release Tablets, 81 mg

Drug Facts

Active Ingredient (in each tablet)

Purpose

Aspirin 81 mg (NSAID*)

Pain reliever

*nonsteroidal anti-inflammatory drug

Us es

for the temporary relief of minor aches and pains 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.

ask your doctor about other uses for 81 mg Aspirin

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

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 reliever/fever reducer

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 are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if you are taking

a prescription drug for diabetes, gout, or 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

pain gets worse or lasts for more than 10 days

redness or swelling is present

any new symptoms occur

ringing in the ears or loss of hearing occurs

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 definitely directed to do so by a doctor because

it may cause problems in the unborn child or complications during delivery.

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.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs

or symptoms.

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

Other information

store at room temperature

read all product information before using. Keep this box for important information

Inactive ingredients

Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow

#10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro

crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc,

titanium dioxide, triethyl citrate

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions

Compare to the Active Ingredients in

Bayer Low Dose

Aspirin Delayed Release Tablets, 81 mg

TO OPEN

PUSH IN TAB AND PULL OUT

25 Pouches of 2 Caplets Each

CHRONIC PAIN/FEVER RELIEF

aspirin delayed release tablets, 81 mg tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 5-0 0 2

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

BRO WN IRO N O XIDE (UNII: 1N0 32N7MFO)

METHACRYLIC ACID (UNII: 1CS0 2G8 6 56 )

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

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TALC (UNII: 7SEV7J4R1U)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 5-0 0 2-25

25 in 1 BOX

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:70 0 0 5-0 0 2-50

50 in 1 BOX

2

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:70 0 0 5-0 0 2-0 2

2 in 1 POUCH

3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

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 2/0 9 /20 16

Labeler -

We Care Distributor Inc. (079832998)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

We Care Distributor Inc.

Elysium Pharmaceutical Ltd.

9 156 6 448 6

ma nufa c ture (70 0 0 5-0 0 2)

Revised: 3/2016