Right Remedies

Right Remedies
SPL v3
SPL
SPL Set ID 9399d69e-04ab-4109-8f30-c38f1c15c78c
Route
ORAL
Published
Effective Date 2021-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-06-09

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81 mg (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 81 mg Aspirin

Section 50565-1

Keep out of reach of children.

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 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

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 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

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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Packaging

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

do not take more than 48 tablets in 24 hours

 children under 12 years consult a doctor

Other Information

store at 20º -25°C (68° - 77°F)

 Avoid excessive heat above 40°C (104°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, fumed silica, methacrylic acid and ethyl acrylate co-polymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

Questions Or Comments?

call 1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Tablet)

Aspirin 81 mg (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 81 mg Aspirin

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Pain reliever

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 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

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 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

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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Packaging

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

do not take more than 48 tablets in 24 hours

 children under 12 years consult a doctor

Other Information (Other information)

store at 20º -25°C (68° - 77°F)

 Avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, fumed silica, methacrylic acid and ethyl acrylate co-polymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

Questions Or Comments? (Questions or comments?)

call 1-888-577-8033 Monday - Friday 8am - 4pm EST

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

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)