Major 44-183

Major 44-183
SPL v4
SPL
SPL Set ID 640c3311-2abf-40b2-82b9-9fe4d8c1cf1d
Route
ORAL
Published
Effective Date 2023-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Anhydrous Citric Acid Hypromellose, Unspecified Microcrystalline Cellulose Dimethicone 410 Sodium Lauryl Sulfate Talc Titanium Dioxide Polyethylene Glycol, Unspecified Propylene Glycol Shellac Starch, Corn Sodium Phosphate, Dibasic, Anhydrous Silicon Dioxide Hydrogenated Cottonseed Oil

Identifiers & Packaging

Pill Appearance
Imprint: 44;183 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-03-30

Description

Buffered aspirin equal to 325 mg aspirin (NSAID)* (buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) *nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Buffered aspirin equal to 325 mg aspirin (NSAID)* (buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) *nonsteroidal anti-inflammatory drug 

Uses
  • temporarily relieves minor aches and pains associated with:
    • o
      toothache
    • o
      minor pain of arthritis
    • o
      backache
    • o
      the common cold

    • o
      headache
    • o
      muscular aches

    • o
      premenstrual & menstrual cramps
  • temporarily reduces fever 
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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug 
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Do Not Use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • each tablet contains: calcium 35 mg and magnesium 40 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions Or Comments?

(800) 616-2471

Principal Display Panel

NDC 71205-517-30

Compare to the active ingredient in BUFFERIN®†

TRI-BUFFERED

ASPIRIN

325 mg

pain reliever/fever reducer (NSAID)

30 TABLETS

This product is not manufactured or distributed by Dr. Reddy's Laboratories Inc., owner of the registered trademark Bufferin®.

50844     REV0318M18312

Distributed by MAJOR ® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233 

Livonia, MI 48152 USA 

Repackaged by Proficient Rx LP

Thousand Oaks, CA 91320 

   

M-17

Re-order No. 700594    Rev. 07/18

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Ask A Doctor Before Use If
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma 
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease



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:
    • o
      feel faint
    • o
      vomit blood
    • o
      have bloody or black stools
    • o
      have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • 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

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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Buffered aspirin equal to

325 mg aspirin (NSAID)*

(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)

*nonsteroidal anti-inflammatory drug 

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • arthritis
  • diabetes

Structured Label Content

Uses
  • temporarily relieves minor aches and pains associated with:
    • o
      toothache
    • o
      minor pain of arthritis
    • o
      backache
    • o
      the common cold

    • o
      headache
    • o
      muscular aches

    • o
      premenstrual & menstrual cramps
  • temporarily reduces fever 
Purpose

Pain reliever/fever reducer

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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug 
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Do Not Use (Do not use)
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (Other information)
  • each tablet contains: calcium 35 mg and magnesium 40 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

(800) 616-2471

Principal Display Panel

NDC 71205-517-30

Compare to the active ingredient in BUFFERIN®†

TRI-BUFFERED

ASPIRIN

325 mg

pain reliever/fever reducer (NSAID)

30 TABLETS

This product is not manufactured or distributed by Dr. Reddy's Laboratories Inc., owner of the registered trademark Bufferin®.

50844     REV0318M18312

Distributed by MAJOR ® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233 

Livonia, MI 48152 USA 

Repackaged by Proficient Rx LP

Thousand Oaks, CA 91320 

   

M-17

Re-order No. 700594    Rev. 07/18

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma 
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease



Stop Use and Ask A Doctor If (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:
    • o
      feel faint
    • o
      vomit blood
    • o
      have bloody or black stools
    • o
      have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • 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

These could be signs of a serious condition. 

If Pregnant Or Breast Feeding, (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. (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Buffered aspirin equal to

325 mg aspirin (NSAID)*

(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)

*nonsteroidal anti-inflammatory drug 

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

  • gout
  • arthritis
  • diabetes

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)