Alka-seltzer Extra Strength

Alka-seltzer Extra Strength
SPL v5
SPL
SPL Set ID 49b73bd5-6465-05eb-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2010-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (1000 mg) Sodium Cation (1985 mg) Aspirin (500 mg)
Inactive Ingredients
Lemon

Identifiers & Packaging

Pill Appearance
Imprint: ALKA;SELTZER;EX;S Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-04-11

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

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
Section 53414-9

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.

Section 55105-1
Active ingredients (in each tablet) Purpose
Anhydrous citric acid 1000 mg Antacid
Aspirin 500 mg Analgesic
Sodium bicarbonate (heat-treated) 1985 mg Antacid
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 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
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
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
  • 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)

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
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


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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

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
Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purpose
Anhydrous citric acid 1000 mg Antacid
Aspirin 500 mg Analgesic
Sodium bicarbonate (heat-treated) 1985 mg Antacid
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 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
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
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)
  • 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 (Inactive ingredients)

flavor

Questions Or Comments? (Questions or comments?)

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

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
Principal Display Panel 24 Tablets Carton (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)