leader extra strength effervescent antacid & pain reliever

leader extra strength effervescent antacid & pain reliever
SPL v3
SPL
SPL Set ID c5d7bf5f-3e59-52f2-e053-2a95a90a4a00
Route
oral
Published
Effective Date 2021-06-25
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 2021-06-25 Until 2027-02-28

Purpose

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


Medication Information

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

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

Purpose

(in each effervescent tablet)

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

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

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

*Nonsteroidal anti-inflammatory drug

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

Other Information

each tablet contains: sodium 575 mg

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

Inactive Ingredients

flavor

Description

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

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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.

Active Ingredients

(in each effervescent tablet)

Anhydrous citric acid 1000 mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Questions Or Comments?

1-888-228-6937

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

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

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

Purpose

(in each effervescent tablet)

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

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

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

*Nonsteroidal anti-inflammatory drug

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

Other Information (Other information)

each tablet contains: sodium 575 mg

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

Inactive Ingredients (Inactive ingredients)

flavor

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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.

Active Ingredients (Active ingredients)

(in each effervescent tablet)

Anhydrous citric acid 1000 mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Questions Or Comments? (Questions or comments?)

1-888-228-6937

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

All Sections (JSON)