NDC 0280-4020 Alka-seltzer Lemon Lime

Alka-seltzer Lemon Lime

NDC Product Code 0280-4020

NDC CODE: 0280-4020

Proprietary Name: Alka-seltzer Lemon Lime 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: Alka-seltzer Lemon Lime 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):
ALKA;SELTZER;ANTACID
Score: 1
Flavor(s):
LEMON (C73396)

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.

NDC 0280-4020-36

Package Description: 18 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Alka-seltzer Lemon Lime with NDC 0280-4020 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Lemon Lime is alka-seltzer lemon lime. The product's dosage form is tablet, effervescent and is administered via oral form.

Labeler Name: Bayer Healthcare Llc.

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.

Alka-seltzer Lemon Lime 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.

  • ANHYDROUS CITRIC ACID 1000 mg/1
  • SODIUM BICARBONATE 1700 mg/1
  • ASPIRIN 325 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ASPARTAME (UNII: Z0H242BBR1)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: Bayer Healthcare Llc.
Labeler Code: 0280
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-07-2014 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Sodium Bicarbonate

Sodium Bicarbonate is pronounced as (soe' dee um) (bye kar' bon ate)

Why is sodium bicarbonate medication prescribed?
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic...
[Read More]
Simethicone

Simethicone is pronounced as (sye meth' i kone)
Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Aspirin

Aspirin is pronounced as (as' pir in)
Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]
Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]
Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)
Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]

* Please review the disclaimer below.

Alka-seltzer Lemon Lime Product Label Images

Alka-seltzer Lemon Lime 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

Otc - Active Ingredient

Anhydrous citric acid 1000 mg.................................………AntacidAspirin 325 mg (NSAID)



nonsteroidal anti-inflammatory drug…………………….……………Analgesic



Sodium bicarbonate (heat-treated) 1700 mg.……………..Antacid

Otc - Purpose

Anhydrous citric acid 1000 mg............................ AntacidAspirin 325 mg (NSAID)*.................................Analgesic

Sodium bicarbonate (heat-treated) 1700 mg...... Antacid

*nonsteroidal anti-inflammatory drug

Indications & Usage

For the temporary relief of● heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains● upset stomach with headache from overindulgence in food or drink● pain alone (headache or body and muscular 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) · shockStomach 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

Otc - Do Not Use

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

Otc - Ask Doctor

● 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

Otc - Ask Doctor/Pharmacist

● presently taking a prescription drug. Antacids may interact with certain prescription drugs.● taking a prescription drug for diabetes, gout, or arthritis

Otc - When Using

When using this product do not exceed recommended dosage

Otc - Stop Use

● an allergic reaction occurs. Seek medical help right away.● 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● symptoms get worse or last more than 10 days● redness or swelling is present● ringing in the ears or a loss of hearing occurs● new symptoms occur

Otc - Pregnancy Or Breast Feeding

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.

Dosage & Administration

Directions● fully dissolve 2 tablets in 4 ounces of water before takingadults and children 12 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 8 tablets in 24hoursadults 60 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 4 tablets in 24 hourschildren under 12 yearsconsult a doctorconsult a doctor

Other Safety Information





each tablet contains: sodium 504 mg



● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet● store at room temperature. Avoid excessive heat.● Alka-Seltzer Lemon Lime in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredient

Aspartame, docusate sodium, flavor, povidone, sodium benzoate

Otc - Questions

Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

* Please review the disclaimer below.