Chewable Aspirin: Package Insert and Label Information

CHEWABLE ASPIRIN- aspirin tablet, chewable
MARC GLASSMAN, 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 (in each tablet)

Aspirin 81 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains or as recommended by your doctor
  • ask your doctor about other uses for this product

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 you have ever had an allergic reaction to 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

  • 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:

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

These could be signs of a serious condition.

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 (1-800-222-1222).

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 between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information and warnings

Inactive ingredients

corn starch, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, silicon dioxide, sucrose

PRINCIPAL DISPLAY PANEL

NDC 68998-205-01

†Compare to the active ingredient in Bayer® Chewable Aspirin

Marc’s®

low dose

Orange Flavored

Chewable Aspirin

PAIN RELIEVER (NSAID)

81 mg

Talk to your doctor or other healthcare provider before using this product for your heart

Actual Size

36 Tablets

image description
(click image for full-size original)
CHEWABLE ASPIRIN
aspirin tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-205
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
STARCH, CORN
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
SILICON DIOXIDE
SUCROSE
Product Characteristics
Color orange Score no score
Shape ROUND Size 8mm
Flavor ORANGE Imprint Code AP;009
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68998-205-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (68998-205-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/31/2021
Labeler — MARC GLASSMAN, INC. (094487477)

Revised: 11/2021 MARC GLASSMAN, INC.

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