Dr. Juans Santo Remedio PARA LA ACIDEZ

Manufacturer
Santo Remedio LLC.
Effective date
2022-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:47

Label at a glance#

ProductDr. Juans Santo Remedio PARA LA ACIDEZ
Active ingredientASPIRIN, SODIUM BICARBONATE, ANHYDROUS CITRIC ACID
Label structure17 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 1000 mg

Aspirin 325 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Anydrous citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid

Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever

Sodium bicarbonate (heat-treated) 1916 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

Do not use ■ if you are allergic to aspirin or any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if

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 ■ you have asthma ■ 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, expect 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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 524 mg

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

■ none

Questions or comments?

OTC - QUESTIONS SECTION

Distributed By

Santo Remedio, LLC

Miami, FL - 855-REMEDIO

misantoremedio.com

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Santo Remedio Pain 20Santo Remedio Pain 20

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81352-42181352-421-20

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ef6c06e5-62e2-dd42-e053-2a95a90aad16c6f2939b-e41a-310f-e053-2995a90aed7f2022-12-09WarningsExact identifier
spl id: ef6c06e5-62e2-dd42-e053-2a95a90aad16
spl set id: c6f2939b-e41a-310f-e053-2995a90aed7f

Reported adverse events (FAERS/openFDA)#

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