Drug Mart Effervescent Pain Relief

Drug Mart Effervescent Pain Relief
SPL v4
SPL
SPL Set ID 8bc65603-1dbf-30ab-e053-2995a90a7c15
Route
ORAL
Published
Effective Date 2015-01-28
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 2015-01-28 Until 2026-12-31

Description

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

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

Uses

■ 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 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 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

children under 12 years: consult a doctor

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

■ 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

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

In Case of Overdose,

get medical help or contact a Poison Control Center right away.

Inactive Ingredients

■ none

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

■ 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

■ 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 Breastfeeding,

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. Princiipal 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

■ 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 50565-1 (50565-1)

Keep out of reach of children.

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

children under 12 years: consult a doctor

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 (Other information)

each tablet contains: sodium 524 mg

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

Active Ingredients (Active ingredients)

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

In Case of Overdose, (In case of overdose,)

get medical help or contact a Poison Control Center right away.

Inactive Ingredients (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 Breastfeeding, (If pregnant or breastfeeding,)

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. 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)

■ 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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