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Name:Alka-seltzer Xtra Strength
Manufacturer:Bayer Bitterfeld Gmbh
Category:Over-the-counter (OTC) Marketed Drugs


Alka- Seltzer®XTRA STRENGTH

ALKA-SELTZER XTRA STRENGTH - anhydrous citric acid, sodium bicarbonate and aspirin granule, effervescent 
Bayer Bitterfeld GmbH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alka-
Seltzer®
XTRA
STRENGTH

Drug Facts

Active ingredients (in each tablet) Purpose
Anhydrous citric acid 1000 mg Antacid
Aspirin 500 mg Analgesic
Sodium bicarbonate (heat-treated) 1985 mg Antacid

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
  • facial swelling
  • asthma (wheezing)
  • shock

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.

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if you have

  • asthma
  • ulcers
  • bleeding problems
  • stomach problems that last or come back frequently, such as heartburn, upset stomach, or pain
  • 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 (blood thinning), diabetes, gout, or arthritis

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • symptoms get worse or last more than 10 days
  • redness or swelling is present
  • ringing in the ears or 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.

Directions

  • fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over 2 tablets every 6 hours, or as directed by a doctor do not exceed 7 tablets in 24 hours
adults 60 years and over 2 tablets every 6 hours, or as directed by a doctor do not exceed 3 tablets in 24 hours
children under 12 years consult a doctor

Other information

  • each tablet contains: sodium 588 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer Extra Strength in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

flavor

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 24 Tablets Carton

Alka-
Seltzer
®

ANTACID & PAIN RELIEF MEDICINE

FAST
RELIEF
OF:

Acid Indigestion
Upset Stomach
Heartburn with
Headache
Body Aches

XTRA
STRENGTH

24 EFFERVESCENT
TABLETS

Principal Display Panel

ALKA-SELTZER XTRA STRENGTH 
anhydrous citric acid, sodium bicarbonate, and aspirin granule, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65662-403
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Anhydrous Citric Acid (Anhydrous Citric Acid) Anhydrous Citric Acid 1000 mg
Sodium Bicarbonate (Sodium Cation) Sodium Bicarbonate 1985 mg
Aspirin (Aspirin) Aspirin 500 mg
Product Characteristics
Color WHITE (White tablet) Score no score
Shape ROUND Size 25mm
Flavor Imprint Code ALKA;SELTZER;EX;S
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65662-403-24 24 PACKET ( PACKET) in 1 CARTON contains a PACKET
1 1 GRANULE, EFFERVESCENT ( TABLET) in 1 PACKET This package is contained within the CARTON (65662-403-24)
2 NDC:65662-403-12 12 PACKET ( PACKET) in 1 CARTON contains a PACKET
2 1 GRANULE, EFFERVESCENT ( TABLET) in 1 PACKET This package is contained within the CARTON (65662-403-12)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/2010

Labeler - Bayer Bitterfeld GmbH (330908898)

Revised: 03/2010 Bayer Bitterfeld GmbH



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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