Equate Extra Strength Effervescent Antacid and Pain Relief

Manufacturer
Walmart Inc.
Effective date
2021-11-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:26:41

Label at a glance#

ProductEquate Extra Strength Effervescent Antacid and Pain Relief
Active ingredientASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE
Label structure16 sections

Indications and uses

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 ■ headache, body aches and pain alone

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. ■ children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each effervescent tablet)

Anhydrous citric acid 1000mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Anhydrous citric acid 1000mg……………………………………...Antacid

Aspirin 500 mg (NSAID)*…………………………………………...Pain Reliever

Sodium bicarbonate (heat-treated) 1985 mg…………………….Antacid

*Nonsteroidal anti-inflammatory drug

Uses

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

■ headache, body aches and pain alone

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 an 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

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

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 2 weeks, except under the advice and supervision of a physician.

Stop use and ask a doctor if

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

If pregnant or breast-feeding

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.

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.

■ children under 12 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: sodium 575 mg

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equate Pain Extra Strength 36Equate Pain Extra Strength 36

Products#

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-54049035-540-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
d1177690-47a9-6635-e053-2a95a90a1d7892ae5664-8d2f-d990-e053-2a95a90a55f62021-11-18WarningsExact identifier
spl id: d1177690-47a9-6635-e053-2a95a90a1d78
spl set id: 92ae5664-8d2f-d990-e053-2a95a90a55f6

Reported adverse events (FAERS/openFDA)#

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