Gencare-aspirin Low Dose Pain Reliever (nsaid)

Gencare-aspirin Low Dose Pain Reliever (nsaid)
SPL v2
SPL
SPL Set ID 24d4f46a-c7a5-4e94-804f-1e307d8e8cfc
Route
ORAL
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Triacetin Stearic Acid Povidone Triethyl Citrate Sodium Lauryl Sulfate Microcrystalline Cellulose Starch, Corn Silicon Dioxide Ethyl Acrylate And Methyl Methacrylate Copolymer (2:1; 600000 Mw) Titanium Dioxide Sodium Bicarbonate Talc D&c Yellow No. 10 Hypromellose 2910 (6 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: S17 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-07

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

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

Uses:

• 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 Safety Coated 81 mg Aspirin

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking a prescription drug for • gout • diabetes • arthritis

Section 50569-3

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
Section 51945-4

Pregnancy

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.

Warnings:

Reye's syndrome

Children and teenagers who have or are recovering from chickenpox 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 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
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. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

Triacetin, Stearic Acid, Povidone, Triethyl citrate, Sodium Lauryl Sulfate, Microcrystalline Cellulose, Starch Corn, Pregelatinized Starch, Silicon Dioxide, Methacrylic Acid - Ethyl Acrylate copolymer, Titanium Dioxide, Sodium Bicarbonate, Talc, D & C Yellow No. 10, Hypromellose 2910 (6 Mpa.S)

Questions Or Comments?

Call +1-(732) 994-2808 or email [email protected]

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.

Stop Use and Ask A Doctor If 
  • an allergic reaction occurs. Seek medical help right away
  • you experiance any of the sollowing signs of 
  • stomoch 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
  • ringning in the ears or a loss of hearing occurs
Active Ingredient (in Each Tablet)

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


Structured Label Content

Uses:

• 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 Safety Coated 81 mg Aspirin

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking a prescription drug for • gout • diabetes • arthritis

Section 50569-3 (50569-3)

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
Section 51945-4 (51945-4)

Purpose

Pain reliever

Pregnancy (PREGNANCY)

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.

Warnings:

Reye's syndrome

Children and teenagers who have or are recovering from chickenpox 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 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
Directions (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 (OTHER INFORMATION)

• store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients (INACTIVE INGREDIENTS)

Triacetin, Stearic Acid, Povidone, Triethyl citrate, Sodium Lauryl Sulfate, Microcrystalline Cellulose, Starch Corn, Pregelatinized Starch, Silicon Dioxide, Methacrylic Acid - Ethyl Acrylate copolymer, Titanium Dioxide, Sodium Bicarbonate, Talc, D & C Yellow No. 10, Hypromellose 2910 (6 Mpa.S)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call +1-(732) 994-2808 or email [email protected]

Keep Out of Reach of Children (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.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • an allergic reaction occurs. Seek medical help right away
  • you experiance any of the sollowing signs of 
  • stomoch 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
  • ringning in the ears or a loss of hearing occurs
Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

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


Advanced Ingredient Data


Raw Label Data

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