Effervescent Pain Relief Tablets 36 Ct.

Effervescent Pain Relief Tablets 36 Ct.
SPL v6
SPL
SPL Set ID 44babed8-cf38-1c12-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2014-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (1916 mg) Aspirin (325 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 2006-12-01

Description

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

Purpose

Pain reliever Antacid Antacid


Medication Information

Purpose

Pain reliever

Antacid

Antacid

Description

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

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.

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

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

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 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

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


Structured Label Content

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.

Purpose

Pain reliever

Antacid

Antacid

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

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

(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.

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

Serious Side Effects Associated With the Use of This Product Can Be Reported to the Following Address: (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


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