Alka Seltzer Originial 1s Blister Pack

Alka Seltzer Originial 1s Blister Pack
SPL v3
SPL
SPL Set ID 8876a416-6a8d-466f-932a-dddf673c32be
Route
ORAL
Published
Effective Date 2019-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (1000 mg) Aspirin (325 mg) Bicarbonate Ion (1916 mg)

Identifiers & Packaging

Pill Appearance
Imprint: ALKA;SELTZER Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-30

Description

Anhydrous citric acid 1000 mg Aspirin 325 mg (NSAID) * Sodium bicarbonate (heat-treated) 1916 mg *nonsteroidal anti-inflammatory drug

Purpose

Antacid Analgesic


Medication Information

Purpose

Antacid

Analgesic

Description

Anhydrous citric acid 1000 mg Aspirin 325 mg (NSAID) * Sodium bicarbonate (heat-treated) 1916 mg *nonsteroidal anti-inflammatory drug

Uses

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
  • headache, body aches, and pain alone
Warnings

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. Reye's syndrome: 

Aspirin may cause a severe allergic reaction which may include: Allergy alert: 

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning: 

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • 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
Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

 adults and children 12 years and over  2 tablets every 4 hours, or as directed by a doctor  do not exceed 8 tablets in 24 hours
 adults 60 years and over  2 tablets every 4 hours, or as directed by a doctor  do not exceed 4 tablets in 24 hours
 children under 12 years  consult a doctor
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
Other Information
  • sodium 567 mg each tablet contains:
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
Package Labeling:

Inactive Ingredients

none

Questions Or Comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

When Using This Product

do not exceed recommended dosage

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
Stop Use and Ask A Doctor If
  • 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
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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet)

Anhydrous citric acid 1000 mg

Aspirin 325 mg (NSAID) *

Sodium bicarbonate (heat-treated) 1916 mg *nonsteroidal anti-inflammatory drug

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 diabetes, gout, or arthritis

Structured Label Content

Uses

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
  • headache, body aches, and pain alone
Purpose

Antacid

Analgesic

Warnings

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. Reye's syndrome: 

Aspirin may cause a severe allergic reaction which may include: Allergy alert: 

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning: 

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • 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
Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

 adults and children 12 years and over  2 tablets every 4 hours, or as directed by a doctor  do not exceed 8 tablets in 24 hours
 adults 60 years and over  2 tablets every 4 hours, or as directed by a doctor  do not exceed 4 tablets in 24 hours
 children under 12 years  consult a doctor
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
Other Information (Other information)
  • sodium 567 mg each tablet contains:
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
Package Labeling:

Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

When Using This Product (When using this product)

do not exceed recommended dosage

Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
If Pregnant 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.

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.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Anhydrous citric acid 1000 mg

Aspirin 325 mg (NSAID) *

Sodium bicarbonate (heat-treated) 1916 mg *nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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 diabetes, gout, or arthritis

Advanced Ingredient Data


Raw Label Data

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