Quality Choice Effervescent Antacid & Pain Relief

Quality Choice Effervescent Antacid & Pain Relief
SPL v5
SPL
SPL Set ID 70d265de-ff94-e0e4-e053-2a91aa0a962a
Route
ORAL
Published
Effective Date 2014-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg) Bicarbonate Ion (1916 mg) Anhydrous Citric Acid (1000 mg)

Identifiers & Packaging

Pill Appearance
Imprint: L421 Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-05 Until 2026-12-31

Description

(in each effervescent tablet) Aspirin 325 mg (NSAID)* Citric acid 1000 mg Sodium bicarbonate (heat-treated) 1916 mg *Nonsteroidal anti-inflammatory drug

Purpose

Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid Sodium bicarbonate (heat-treated) 1916 mg . . . . . . Antacid *Nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever

Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid

Sodium bicarbonate (heat-treated) 1916 mg . . . . . . Antacid

*Nonsteroidal anti-inflammatory drug

Description

(in each effervescent tablet) Aspirin 325 mg (NSAID)* Citric acid 1000 mg Sodium bicarbonate (heat-treated) 1916 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

■ pain alone (headaches or body aches and pains)

Section 34088-5

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

Section 53413-1

Serious side effects associated with the use of this product can be reported to the following address:

Tower Laboratories LTD.

P.O. Box 306

8 Industrial Park Road

Centerbrook, CT 06409

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 a nonsteroidal anti-inflammatory drug (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

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

Take this product any time - morning, noon, or night - when you need relief from heartburn, acid indigestion, sour stomach with headache or body aches and pains. Place two (2) tablets in 4 oz. of water. Dissolve tablets completely. You do not have to drink any of the residue that may be on the bottom of the glass. The medicines are in the water.

Do Not Use

Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product.

Other Information

each tablet contains: sodium 524 mg

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

Active Ingredients

(in each effervescent tablet)

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

Inactive Ingredients

■ none

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 10 days

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 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.

Keep Out of Reach of Children.

Keep out of reach of children.

Package Label. Princiipal 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


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

■ pain alone (headaches or body aches and pains)

Section 34088-5 (34088-5)

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

Section 53413-1 (53413-1)

Serious side effects associated with the use of this product can be reported to the following address:

Tower Laboratories LTD.

P.O. Box 306

8 Industrial Park Road

Centerbrook, CT 06409

Purpose

Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever

Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid

Sodium bicarbonate (heat-treated) 1916 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 a nonsteroidal anti-inflammatory drug (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

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

Take this product any time - morning, noon, or night - when you need relief from heartburn, acid indigestion, sour stomach with headache or body aches and pains. Place two (2) tablets in 4 oz. of water. Dissolve tablets completely. You do not have to drink any of the residue that may be on the bottom of the glass. The medicines are in the water.

Do Not Use (Do not use)

Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product.

Other Information (Other information)

each tablet contains: sodium 524 mg

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

Active Ingredients (Active ingredients)

(in each effervescent tablet)

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

■ none

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 10 days

Ask A Doctor Before Use If (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 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.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.

Package Label. Princiipal Display Panel (PACKAGE LABEL. PRINCIIPAL DISPLAY PANEL)

Ask A Doctor Or Pharmacist Before Use If You Are (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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