HEB Extra Strength Effervescent Antacid and Pain Relief

ASPIRIN, CITRIC ACID, SODIUM BICARBONATE ORAL HUMAN OTC DRUG

HEB Extra Strength Effervescent Antacid and Pain Relief is an FDA drug label for the active ingredient ASPIRIN, CITRIC ACID, SODIUM BICARBONATE manufactured by H. E. Butt Grocery Company administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231218.

Generic name
ASPIRIN, CITRIC ACID, SODIUM BICARBONATE
Manufacturer
H. E. Butt Grocery Company
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
37808-540
Application
505G(a)(3)
Label effective
20231218

About this product

HEB Extra Strength Effervescent Antacid and Pain Relief is an FDA-registered drug product whose active ingredient is ASPIRIN, CITRIC ACID, SODIUM BICARBONATE. It is labelled by H. E. Butt Grocery Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 37808-540, application 505G(a)(3), label effective 20231218. It is one of 2 FDA drug label records sharing the active ingredient ASPIRIN, CITRIC ACID, SODIUM BICARBONATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing ASPIRIN, CITRIC ACID, SODIUM BICARBONATE are most often described in connection with: headache body, temporary relief, heartburn acid, sour stomach, pains upset, overindulgence food, pain alone. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each effervescent tablet) Anhydrous citric acid 1000 mg Aspirin 500 mg (NSAID) * Sodium bicarbonate (heat-treated) 1985 mg *Nonsteroidal anti-inflammatory drug

Indications & Usage

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 & Administration

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 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

Warnings

Warnings 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 (anti-coagulant) 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

More products with the same ingredient

ASPIRIN, CITRIC ACID, SODIUM BICARBONATE

Market Basket Effervescent Antacid and Pain Relief

Demoulas Super Markets, Inc. View label

How products containing ASPIRIN, CITRIC ACID, SODIUM BICARBONATE compare

FDA lists 2 drug label records with ASPIRIN, CITRIC ACID, SODIUM BICARBONATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Demoulas Super Markets, Inc. 1
— — H. E. Butt Grocery Company 1
— — — —
— — — —
— — — —

Frequently asked questions

What is HEB Extra Strength Effervescent Antacid and Pain Relief used for?
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

Who makes HEB Extra Strength Effervescent Antacid and Pain Relief?
H. E. Butt Grocery Company is the labeler of record for HEB Extra Strength Effervescent Antacid and Pain Relief. 2 FDA label records share the active ingredient ASPIRIN, CITRIC ACID, SODIUM BICARBONATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does HEB Extra Strength Effervescent Antacid and Pain Relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is HEB Extra Strength Effervescent Antacid and Pain Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ASPIRIN, CITRIC ACID, SODIUM BICARBONATE?
Yes. 2 FDA drug label records list ASPIRIN, CITRIC ACID, SODIUM BICARBONATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has HEB Extra Strength Effervescent Antacid and Pain Relief been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.