Medique Medi Seltzer

Medique Medi Seltzer
SPL v13
SPL
SPL Set ID 528da9d9-2a52-4c16-b7b2-61b3eee1abea
Route
ORAL
Published
Effective Date 2022-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: L421 Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2008-12-30 Until 2027-01-01

Description

Drug Facts


Medication Information

Warnings and Precautions

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

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol drinks every day while using this product
  • take more or for a longer time than directed

Indications and Usage

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
Dosage and Administration

Directions

  • do not exceed recommended dosage
  • to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

Adults and children 12 to 60 years of age: 2 tablets every 4 hours. Do not exceed 8 tablets in 24 hours or do not use the maximum dosage for more than 10 days.

Children under 12 years of age: Do not give to children under 12 years of age.

60 years and older: Do not exceed 4 tablets in 24 hours or do not use the maximum dosage for more than 10 days.

Description

Drug Facts

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 50566-9

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • you feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful area
  • any new symptoms appear
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

  • taking any other drugs (prescription or non-prescription). Antacids may interact with certain drugs.
  • under a doctor's care for any serious condition

Section 50569-3

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 are on a sodium restricted diet
  • you reached age 60 or older
Section 50570-1

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • if you are taking a prescription drug for gout, diabetes or arthritis
Section 51727-6

none

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin (*NSAIDS) at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1

Purpose

Pain reliever /fever reducer

Antacid

Antacid

Section 55106-9

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

Citric Acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*nonsteriodal anti-inflammatory drug

Section 60561-8

Other information

  • each tablet contains: Sodium 524 mg
  • store at room temperature 59º-86º F (15º-30º C)
  • read all product information before using
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets
Medique Medi Seltzer Label

Medique®

Medi-Seltzer

Effervescent Antacid/Pain Reliever

Pull to Open

This Package is for Households without Young Children.

Aches, Fever ● Aspirin (NSAID) 325 mg

Antacid ● Citric Acid 1000 mg Sodium Bicarbonate 1916 mg

72 Tablets

(36 x 2)

Tamper Evident Unit Dose Packets


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

  • do not exceed recommended dosage
  • to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking

Adults and children 12 to 60 years of age: 2 tablets every 4 hours. Do not exceed 8 tablets in 24 hours or do not use the maximum dosage for more than 10 days.

Children under 12 years of age: Do not give to children under 12 years of age.

60 years and older: Do not exceed 4 tablets in 24 hours or do not use the maximum dosage for more than 10 days.

Warnings and Precautions (34071-1)

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

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol drinks every day while using this product
  • take more or for a longer time than directed

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 50566-9 (50566-9)

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • you feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful area
  • any new symptoms appear
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

  • taking any other drugs (prescription or non-prescription). Antacids may interact with certain drugs.
  • under a doctor's care for any serious condition

Section 50569-3 (50569-3)

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 are on a sodium restricted diet
  • you reached age 60 or older
Section 50570-1 (50570-1)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • if you are taking a prescription drug for gout, diabetes or arthritis
Section 51727-6 (51727-6)

none

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin (*NSAIDS) at 20 weeks or later in pregnancy unless specifically 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)

Purpose

Pain reliever /fever reducer

Antacid

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

Citric Acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*nonsteriodal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

  • each tablet contains: Sodium 524 mg
  • store at room temperature 59º-86º F (15º-30º C)
  • read all product information before using
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets
Medique Medi Seltzer Label (Medique Medi-Seltzer Label)

Medique®

Medi-Seltzer

Effervescent Antacid/Pain Reliever

Pull to Open

This Package is for Households without Young Children.

Aches, Fever ● Aspirin (NSAID) 325 mg

Antacid ● Citric Acid 1000 mg Sodium Bicarbonate 1916 mg

72 Tablets

(36 x 2)

Tamper Evident Unit Dose Packets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)