Freds Effervescent Antacid Pain Relief

Manufacturer
Freds, Inc.
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:06:26

Label at a glance#

ProductFreds Effervescent Antacid Pain Relief
Active ingredientASPIRIN, SODIUM BICARBONATE, ANHYDROUS CITRIC ACID
Label structure16 sections

Indications and uses

■ 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)

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 Take this product any time - morning, noon or night - when you need relief from heartburn...

Label contents#

Full prescribing information#

Active ingredients (in each effervescent tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg NSAID*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

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

Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . Antacid

Sodium bicarbonate (heat-treated) 1916 mg . . . ... Antacid

*Nonsteroidal anti-inflammatory drug

Uses for the temporary relief of

INDICATIONS & USAGE SECTION

■ 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)

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 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

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 ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product.

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 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

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 10 days

Stop use and ask a doctor if

OTC - STOP USE SECTION

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 breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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,

OVERDOSAGE SECTION

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

Take this product any time - morning, noon or night - when you need relief from heartburn, acid indigestion, sour stomach with headache or body aches and pains.

Place two (2) tablets in 4 oz. of water. Dissolve tablets completely.

You do not have to drink any of the residue that may be on the bottom of the glass. The medicines are in the water.

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: sodium 524 mg

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

■ none

PACKAGE LABEL. PRINCIIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freds Pain 36ctFreds Pain 36ct

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-42155315-421-36

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
b3ecde9f-6fb7-f3aa-e053-2a95a90ac3628c529a3e-e7e9-497c-e053-2a95a90a2cdc2020-11-12WarningsExact identifier
spl id: b3ecde9f-6fb7-f3aa-e053-2a95a90ac362
spl set id: 8c529a3e-e7e9-497c-e053-2a95a90a2cdc

Reported adverse events (FAERS/openFDA)#

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