Nobleaid Aspirin Pain Reliever

Nobleaid Aspirin Pain Reliever
SPL v4
SPL
SPL Set ID aa08e488-2f69-4d7e-86ba-ccfad563edcf
Route
ORAL
Published
Effective Date 2021-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Microcrystalline Cellulose Silicon Dioxide Talc Croscarmellose Sodium Stearic Acid Titanium Dioxide Triethyl Citrate Methacrylic Acid And Ethyl Acrylate Copolymer D&c Yellow No. 10 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-15

Description

Aspirin 81 mg (NSAID)

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Aspirin 81 mg (NSAID)

Uses

For the temporary relief of minor aches and pains

Section 42229-5

• Safe pain relief

• Safety enteric-coated aspirin regimen

ADULT LOW DOSE

Compare to Bayer® Aspirin active ingredient

Questions or comments?

Please call (347)378-8990 Monday Through Friday 9-5 or by Email [email protected]

This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the Registered Trademark BAYER® Tablets

TAMPER EVIDENT Do not use if safety seal under cap is broken or missing.

Manufactured for

Noble OTC LLC

Perth Amboy, NJ 08861

www.nobleotc.com

Section 50565-1

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.

Warning

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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 non prescription 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.

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 •redness or swelling is present •fever lasts more than 3 days •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.

Packaging

Drug Facts

Directions:

•Drink a full glass of water with each dose •adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours •children under 12 years: consult a doctor.

Other Information:

Store at room temperature

Inactive Ingredients:

Microcrystalline Cellulose, Silicon dioxide, Talcum, Croscarmellose sodium, Stearic acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, D&C Yellow #10, FD&C Yellow #6

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID)


Structured Label Content

Uses

For the temporary relief of minor aches and pains

Section 42229-5 (42229-5)

• Safe pain relief

• Safety enteric-coated aspirin regimen

ADULT LOW DOSE

Compare to Bayer® Aspirin active ingredient

Questions or comments?

Please call (347)378-8990 Monday Through Friday 9-5 or by Email [email protected]

This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the Registered Trademark BAYER® Tablets

TAMPER EVIDENT Do not use if safety seal under cap is broken or missing.

Manufactured for

Noble OTC LLC

Perth Amboy, NJ 08861

www.nobleotc.com

Section 50565-1 (50565-1)

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.

Purpose

Pain Reliever

Warning (WARNING)

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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 non prescription 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.

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 •redness or swelling is present •fever lasts more than 3 days •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.

Packaging

Drug Facts

Directions:

•Drink a full glass of water with each dose •adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours •children under 12 years: consult a doctor.

Other Information:

Store at room temperature

Inactive Ingredients: (Inactive ingredients:)

Microcrystalline Cellulose, Silicon dioxide, Talcum, Croscarmellose sodium, Stearic acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, D&C Yellow #10, FD&C Yellow #6

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

Aspirin 81 mg (NSAID)


Advanced Ingredient Data


Raw Label Data

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