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  5. Label Information: Alka Seltzer

FDA Label for Alka Seltzer

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES FOR THE RELIEF OF:
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS?
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka Seltzer Product Label

The following document was submitted to the FDA by the labeler of this product Salimex, S.a.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Tablet)



Aspirin 325 mg

Citric acid 1000 mg

Sodium Bicarbonate (heat treated) 1916 mg


Purpose



Analgesic, Antacid


Keep Out Of Reach Of Children



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


Uses For The 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



Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

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

  • hives
  • asthma (wheezing)

    • Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.


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

    • Other information

    • each tablet contains: sodium 567 mg
    • store at room temperature. Avoid excessive heat.
    • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients



None


Questions Or Comments?



1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
or www.alkaseltzer.com


Package Label.Principal Display Panel



image description - Alka Seltzer

image description - Alka Seltzer


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