NDC 70000-0421 Leader Effervescent Antacid And Pain Relief

Aspirin, Citric Acid, Sodium Bicarbonate

NDC Product Code 70000-0421

NDC Code: 70000-0421

Proprietary Name: Leader Effervescent Antacid And Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspirin, Citric Acid, Sodium Bicarbonate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
25 MM
Imprint(s):
L421
Score: 1

NDC Code Structure

  • 70000 - Cardinal Health
    • 70000-0421 - Leader Effervescent Antacid And Pain Relief

NDC 70000-0421-1

Package Description: 36 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Leader Effervescent Antacid And Pain Relief with NDC 70000-0421 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Effervescent Antacid And Pain Relief is aspirin, citric acid, sodium bicarbonate. The product's dosage form is tablet, effervescent and is administered via oral form.

Labeler Name: Cardinal Health

Dosage Form: Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Leader Effervescent Antacid And Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASPIRIN 325 mg/1
  • SODIUM BICARBONATE 1916 mg/1
  • ANHYDROUS CITRIC ACID 1000 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Leader Effervescent Antacid And Pain Relief Product Label Images

Leader Effervescent Antacid And Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Purpose

Anhydrous citric acid 1000mg...................AntacidAspirin 325mg...........................................Pain relieverSodium bicarbonate 1916mg....................Antacid

Active Ingredients

(in each effervescent tablet)Anhydrous citric acid 1000mgAspirin 325mg
(NSAID)*Sodium bicarbonate 1916mg*Nonsteroidal anti-inflammatory drug

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)

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 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

■ 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

■ 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

■ 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

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

■ 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,

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

Keep out of reach of children.

In Case Of Overdose,

Get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

■ do not exceed recommended dosage■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before takingadults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours or as directed by a doctordo not exceed 8 tablets in 24 hours60 years and over: 2 tablets every 4 hours or as directed by a doctordo not exceed 4 tablets in 24 hoursChildren under 12 years: consult a doctor

Other Information


each tablet contains: sodium 524 mg
■ store at room temperature (59º-86ºF)

Inactive Ingredients

■ none

* Please review the disclaimer below.

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