Top Value Effervescent Pain Relief

Manufacturer
Tower Laboratories Ltd
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:43:10

Label at a glance#

ProductTop Value Effervescent Pain Relief
Active ingredientSODIUM BICARBONATE, ASPIRIN, ANHYDROUS CITRIC ACID
Label structure16 sections

Indications and 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)

Dosage and administration

■ 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each effervescent tablet)

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Antacid

Antacid

Uses

INDICATIONS & USAGE SECTION

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)

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

■ 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.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ 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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: sodium 524 mg

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

■ none

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

ADVERSE REACTIONS SECTION

Tower Laboratories LTD

P.O. Box 306

8 Industrial Park Road

Centerbrook, CT 06409

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Value Pain 36ctTop Value Pain 36ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN6
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD6
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50201-4213-6Top Value Effervescent Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT186
50201-4213-6Top Value Effervescent Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50201-4213TOP VALUE EFFERVESCENT PAIN RELIEF (ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD]6Current NDC, Legacy NDC, 2 package rows20241215_44babed8-cf38-1c12-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50201-421350201-4213-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
ndc (package): 50201-4213-6
ndc (product): 50201-4213
ndc11 (package): 50201421306
spl id: 2902dd3f-009e-6c01-e063-6294a90ae261
spl set id: 44babed8-cf38-1c12-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.