FDA.reportPublic FDA data

Aspirin Low Dose Chewable Orange

Manufacturer
REMEDYREPACK INC.
Effective date
2022-04-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:04:29

Label at a glance#

ProductAspirin Low Dose Chewable Orange
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommneded by your doctor ask your doctor about other uses for Chewable Aspirin 81 mg

Dosage and administration

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 exceed 48 tablets in 24 hours unless directed by a doctor  children under 12 years  consult a doctor

Storage and handling

store at room temperature (15 0 -30 0 C) Tamper Evident:  do not use if safety seal under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains or as recommneded by your doctor
  • ask your doctor about other uses for Chewable Aspirin 81 mg

Warnings

WARNINGS SECTION

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 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 

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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 are taking a diuretic

Ask a doctor or pharmacist before use if you are 

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 more than 10 days
  • fever get worse or lasts more than 3 days
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 exceed 48 tablets in 24 hours unless directed by a doctor
 children under 12 years consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature (15 0-30 0C)
  • Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Aspirin Low Dose Chewable Orange

GENERIC: Aspirin

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-2422-0

NDC: 70518-2422-1

NDC: 70518-2422-2

NDC: 70518-2422-3

NDC: 70518-2422-4

NDC: 70518-2422-5

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: PH034

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

  • STARCH, CORN
  • STEARIC ACID
  • FD&C YELLOW NO. 6
  • SILICON DIOXIDE
  • SACCHARIN SODIUM
  • DEXTROSE MONOHYDRATE

Remedy_LabelRemedy_Label

MM2MM2

MM3MM3

MM4MM4

MM5MM5

MM6MM6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6794-30EA - Each0904-67940b6b3501-8a59-4d48-864f-25efe4b4475912023-04-07
0904-6794-80EA - Each0904-679478376407-1c58-42be-9458-6e0c6219806812018-11-06
0904-6794-89EA - Each0904-6794b50d3dc8-f0d6-49f7-ac05-baa38562ec1d12018-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-242270518-2422-1, 70518-2422-0, 70518-2422-2, 70518-2422-3, 70518-2422-5, 70518-2422-4
0904-6794

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
ASPIRINR16CO5Y76EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low Dose Chewable OrangeASPIRINMAJOR PHARMACEUTICALSfb3a8e38-e991-49c9-93dc-1d29c0a97ba32026-03-05WarningsExact identifier
ndc (product): 0904-6794
0411e8ff-334f-f09b-e063-6394a90a2bad45f7a703-3c80-414c-a74b-122c57ee309b2023-08-29WarningsExact identifier
spl set id: 45f7a703-3c80-414c-a74b-122c57ee309b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.