OTC Medication Information: Adult Low Dose Enteric Coated Aspirin

ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, coated
REMEDYREPACK 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.

Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for 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 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 your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • 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
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • 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 right away.

Directions

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at room temperature 15⁰C — 30⁰C (59⁰F — 86⁰F)
  • for institutional use only

Inactive ingredients

cellulose, D &C yellow
#10, FD&C yellow #6, hypromellose, iron oxide,
methacrylic acid, PEG, polydextrose, propylene
glycol, silica, simethicone, sodium bicarbonate,
sodium lauryl sulfate, starch, talc, titanium dioxide,
triacetin, triethyl citrate, wax. May also contain:
acetylated monoglycerides, croscarmellose sodium,
hypromellose phthalate, lactose, mineral oil,
polysorbate 80, stearic acid.

DRUG: Adult Low Dose Enteric Coated Aspirin

GENERIC: Aspirin

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-0928-0

NDC: 70518-0928-1

NDC: 70518-0928-2

NDC: 70518-0928-3

NDC: 70518-0928-4

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: L

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

  • DIMETHICONE
  • FERROSOFERRIC OXIDE
  • SILICON DIOXIDE
  • SODIUM BICARBONATE
  • SHELLAC
  • SODIUM LAURYL SULFATE
  • TRIACETIN
  • TALC
  • TITANIUM DIOXIDE
  • PROPYLENE GLYCOL
  • D&C YELLOW NO. 10
  • FD&C YELLOW NO. 6
  • HYPROMELLOSES
  • STARCH, CORN
  • POLYETHYLENE GLYCOLS
  • CELLULOSE, MICROCRYSTALLINE
  • POLYDEXTROSE
  • METHACRYLIC ACID
  • TRIETHYL CITRATE
Remedy_Label
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MM2
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MM3
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MM4
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MM5
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ADULT LOW DOSE ENTERIC COATED ASPIRIN
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0928(NDC:57896-981)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYPROMELLOSES
METHACRYLIC ACID
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
DIMETHICONE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-0928-0 30 TABLET, COATED in 1 BLISTER PACK None
2 NDC:70518-0928-1 28 TABLET, COATED in 1 BLISTER PACK None
3 NDC:70518-0928-2 90 TABLET, COATED in 1 BOTTLE, PLASTIC None
4 NDC:70518-0928-3 100 POUCH in 1 BOX contains a POUCH (70518-0928-4)
4 NDC:70518-0928-4 1 TABLET, COATED in 1 POUCH This package is contained within the BOX (70518-0928-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 01/04/2018
Labeler — REMEDYREPACK INC. (829572556)

Revised: 11/2019 REMEDYREPACK INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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