FDA.reportPublic FDA data

Pain Relief

Manufacturer
Select Brand
Effective date
2014-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:24

Label at a glance#

ProductPain Relief Fast Relief
Active ingredientAspirin, Citric Acid Monohydrate, Sodium Bicarbonate
Label structure9 sections

Indications and uses

For the temporary relief of: heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains upset stomach with headache from overindulgence in food or drink headache, body aches and pain alone

Dosage and administration

Dissolve tablets in 4 ounces of water before taking Adults and Children 12 Years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours 60 Years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours

Storage and handling

Each tablet contains: sodium 540 mg store at room temperature. Avoid excessive heat in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each effervescent tablet)Purpose
Aspirin (NSAID) * 325 mgPain reliever
Citric acid 1000 mgAntacid
Sodium bicarbonate (heat-treated) 1916 mgAntacid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of: heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains

  • upset stomach with headache from overindulgence in food or drink
  • headache, body aches and pain alone

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a sever allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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 other drugs containing prescription or nonprescription NSAID's (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer time than directed

Alcohol warning

SPL UNCLASSIFIED SECTION

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.

SPL UNCLASSIFIED SECTION

Aspirin may cause stomach bleeding.

OTC - DO NOT USE SECTION

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

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 asthma
  • you have a sodium-restricted diet

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis.

OTC - WHEN USING SECTION

When using this product do not exceed the recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • symptoms get worse or last more than 10 days
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dissolve tablets in 4 ounces of water before taking
Adults and Children 12 Years and over
  • 2 tablets every 4 hours, or as directed by a doctor
  • do not exceed 8 tablets in 24 hours
60 Years and over
  • 2 tablets every 4 hours, or as directed by a doctor
  • do not exceed 4 tablets in 24 hours

Other information

STORAGE AND HANDLING SECTION

  • Each tablet contains: sodium 540 mg
  • store at room temperature. Avoid excessive heat
  • in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

SPL UNCLASSIFIED SECTION

Distributed by
select brand® /SAJ Distributors
3017 N. Midland Drive
Pine Bluff, AR 71603

PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 15127-968-36

select brand®
the lower price name brand

FAST RELIEF

EFFERVESCENT
Pain Relief

Aspirin (NSAID) / Pain reliever,
Citric acid / Antacid, Sodium bicarbonate / Antacid.

Relieves:
Heartburn • Acid Indigestion
• Sour Stomach with
Headache
• Body Aches
and Pain

Compare to Active
Ingredients in
Alka-Seltzer®*

36 EFFERVESCENT
TABLETS

PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN1
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD1
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY1

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15127-968-362020-01-31C16284748780-19d75b9d0-6586-f424-e053-dadaa90a57ceEffervescent Pain Relief Fast Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-968-36Pain Relief Fast Relief18 in 1 CARTONTABLET, EFFERVESCENT181
15127-968-36Pain Relief Fast Relief2 in 1 PACKETTABLET, EFFERVESCENT21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-968PAIN RELIEF FAST RELIEF (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [SELECT BRAND]1Legacy NDC, 2 package rows20141001_cdf3f813-75cd-4c9f-9585-911b080216b3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AspirinACTIVE INGREDIENTR16CO5Y76E1
Citric Acid MonohydrateACTIVE INGREDIENT2968PHW8QP1
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QO1
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL1
AspirinACTIVE MOIETYR16CO5Y76E1
Bicarbonate IonACTIVE MOIETYHN1ZRA3Q201

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15127-96815127-968-36

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
AspirinR16CO5Y76EACTIB
Citric Acid Monohydrate2968PHW8QPACTIM
Sodium Bicarbonate8MDF5V39QOACTIB

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
38d13846-3bb0-4e2b-ad24-052cf9ddc4f1cdf3f813-75cd-4c9f-9585-911b080216b32014-09-10WarningsExact identifier
spl id: 38d13846-3bb0-4e2b-ad24-052cf9ddc4f1
spl set id: cdf3f813-75cd-4c9f-9585-911b080216b3

Reported adverse events (FAERS/openFDA)#

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