Quality Choice Effervescent Antacid And Pain Relief Extra Strength

Quality Choice Effervescent Antacid And Pain Relief Extra Strength
SPL v3
SPL
SPL Set ID 9f7d0c96-a561-a8a0-e053-2995a90a250b
Route
ORAL
Published
Effective Date 2020-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (1985 mg) Aspirin (500 mg) Anhydrous Citric Acid (1000 mg)
Inactive Ingredients
Lemon

Identifiers & Packaging

Pill Appearance
Imprint: PXS Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-04

Description

(in each effervescent tablet) Anhydrous citric acid 1000mg Aspirin 500 mg (NSAID)* Sodium bicarbonate (heat-treated) 1985 mg *Nonsteroidal anti-inflammatory drug

Purpose

Anhydrous citric acid 1000mg………………………………………..........Antacid Aspirin 500 mg (NSAID)* ………………………………………..........…...Pain Reliever Sodium bicarbonate (heat-treated) 1985 mg……………………...…….Antacid *Nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Anhydrous citric acid 1000mg………………………………………..........Antacid

Aspirin 500 mg (NSAID)*………………………………………..........…...Pain Reliever

Sodium bicarbonate (heat-treated) 1985 mg……………………...…….Antacid

*Nonsteroidal anti-inflammatory drug

Description

(in each effervescent tablet) Anhydrous citric acid 1000mg Aspirin 500 mg (NSAID)* Sodium bicarbonate (heat-treated) 1985 mg *Nonsteroidal anti-inflammatory drug

Uses

Uses for the temporary relief of

■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains

■ upset stomach with headache from overindulgence in food or drink

■ headache, body aches and pain alone

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

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 (anti-coagulant) 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

Directions

■ do not exceed recommended dosage

■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours - do not exceed 8 tablets in 24 hours

60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hours

Children under 12 years: consult 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: sodium 575 mg

■ store at room temperature (59º-86ºF)

Active Ingredients

(in each effervescent tablet)

Anhydrous citric acid 1000mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Inactive Ingredients:

flavor

Questions Or Comments?

1-800-935-2361

When Using This Product

​When using this product do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

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

■ you have a sodium-restricted diet

Stop Use and Ask A Doctor If

Stop use and ask a doctor if ■ 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

■ an allergic reaction occurs. Seek medical help right away.

■ pain lasts for more than 10 days or gets worse

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

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.

Package Label.principal Display Panel

Ask A Doctor Or Pharmacist Before Use If You Are

■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.

■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis


Structured Label Content

Uses

Uses for the temporary relief of

■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains

■ upset stomach with headache from overindulgence in food or drink

■ headache, body aches and pain alone

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Anhydrous citric acid 1000mg………………………………………..........Antacid

Aspirin 500 mg (NSAID)*………………………………………..........…...Pain Reliever

Sodium bicarbonate (heat-treated) 1985 mg……………………...…….Antacid

*Nonsteroidal anti-inflammatory drug

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 (anti-coagulant) 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

Directions

■ do not exceed recommended dosage

■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours - do not exceed 8 tablets in 24 hours

60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hours

Children under 12 years: consult 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: sodium 575 mg

■ store at room temperature (59º-86ºF)

Active Ingredients (Active ingredients)

(in each effervescent tablet)

Anhydrous citric acid 1000mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Inactive Ingredients:

flavor

Questions Or Comments? (Questions or comments?)

1-800-935-2361

When Using This Product (When using this product)

​When using this product do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

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 high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

■ you have asthma

■ you have a sodium-restricted diet

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if ■ 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

■ an allergic reaction occurs. Seek medical help right away.

■ pain lasts for more than 10 days or gets worse

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

If Pregnant Or Breast Feeding (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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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

■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.

■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis


Advanced Ingredient Data


Raw Label Data

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