Effervescent Antacid and Pain Relief

Manufacturer
Cardinal Health Inc. | United Exchange Corporation | Tower Laboratories Ltd
Effective date
2012-09-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:45:32

Label at a glance#

ProductEffervescent Antacid and Pain Relief
Active ingredientSODIUM BICARBONATE, ANHYDROUS CITRIC ACID, ASPIRIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each effervescent tablet)                                      Purpose

Aspirin 325mg NSAID* .............................................                            Pain Reliever
Citric Acid 1000 mg ...................................................                                   Antacid
Sodium Bicarbonate (heat-treated) 1916 mg ................                                    Antacid

*Nonsteroidal anti-inflammatory drug

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers should not use this drug 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: Aspirin may casue a sever 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.

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.

 

INDICATIONS & USAGE SECTION

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)

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

 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

OTC - DO NOT USE SECTION

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 sever stomach pain occurs after taking this product.

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.

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 - STOP USE SECTION

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

OTC - WHEN USING SECTION

When using this product do not take more than 8 tables (adults) and 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days.

OTC - PURPOSE SECTION

Fast Relief of: Indigestion, Upset stomach, Heartburn with headache, Body Aches and Pains.

DOSAGE & ADMINISTRATION SECTION

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 esceed 8 tablets in 24 hours
60 year and over

2 tablets every 4 hours
do not exceed 4 tablets in 24 hours

INACTIVE INGREDIENT SECTION

There are no inactive ingredients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-196-682025-05-07C16284748780-19d75b9d0-880f-f424-e053-dadaa90a57ceDrug Facts
37205-196-682020-01-31C16284748780-19d75b9d0-880f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-196-68EA - Each37205-196a796fb56-e740-4419-917d-7a77c78550c912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSL4
ASPIRINACTIVE INGREDIENTR16CO5Y76E4
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO4
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL4
ASPIRINACTIVE MOIETYR16CO5Y76E4
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q204

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
37205-19637205-196-68

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
338899f5-9a3d-436d-bcb3-ba988abf03acabd781d2-b94c-4527-91a9-5abf7bd875de2025-04-04WarningsExact identifier
spl set id: abd781d2-b94c-4527-91a9-5abf7bd875de

Reported adverse events (FAERS/openFDA)#

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