FDA.reportPublic FDA data

Effervescent Pain Relief

Manufacturer
Western Family Foods, Inc.
Effective date
2014-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:31

Label at a glance#

ProductEffervescent Pain 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

completely dissolve tablets in 4 ounces of water before taking Adults and children 12 years and over 2 tablets every 4 hours do not exceed 8 tablets in 24 hours 60 years and older 2 tablets every 4 hours do not exceed 4 tablets in 24 hours

Storage and handling

each tablet contains: sodium 540 mg protect from 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 severe 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 a blood thinning (anticoagulant) or steroid drug
  • 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

SPL UNCLASSIFIED SECTION

Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Do not use if

OTC - DO NOT USE SECTION

  • you have ever had an allergic reaction to any other pain reliever/fever reducer
  • you are allergic to aspirin

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

Ask a doctor or pharmacist before use if

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

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 have 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
  • 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

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

  • completely dissolve tablets in 4 ounces of water before taking
Adults and children
12 years and over		2 tablets every 4 hours do not exceed 8 tablets in 24 hours
60 years and older2 tablets every 4 hours do not exceed 4 tablets in 24 hours

Other Information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 540 mg
  • protect from 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

Proudly Distributed by
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208 U.S.A.

PRINCIPAL DISPLAY PANEL - 36 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WESTERN
FAMILY®

Antacid & Pain Relief Medicine
Effervescent
PAIN RELIEF

Aspirin (NSAID) / Pain Reliever, Citric Acid /
Antacid, Sodium Bicarbonate / Antacid

FAST RELIEF OF:

Acid Indigestion, Upset Stomach, Heartburn
With Headache, Body Aches & Pains

36
TABLETS

COMPARE TO ALKA-SELTZER® active ingredients*

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
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
55312-469-802020-01-31C16284748780-19d75b9d0-bd91-f424-e053-dadaa90a57ceEffervescent Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-469-80Effervescent Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT181
55312-469-80Effervescent Pain Relief2 in 1 PACKETTABLET, EFFERVESCENT21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-469EFFERVESCENT PAIN RELIEF (ASPIRIN, CITRIC ACID MONOHYDRATE, AND SODIUM BICARBONATE) TABLET, EFFERVESCENT [WESTERN FAMILY FOODS, INC.]1Legacy NDC, 2 package rows20141015_275d4196-52da-4cd1-a90c-ced7ea02526e.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
55312-46955312-469-80

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
263388c7-5033-49c2-9e57-70f2fddea65a275d4196-52da-4cd1-a90c-ced7ea02526e2014-10-07WarningsExact identifier
spl id: 263388c7-5033-49c2-9e57-70f2fddea65a
spl set id: 275d4196-52da-4cd1-a90c-ced7ea02526e

Reported adverse events (FAERS/openFDA)#

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