Medique Medi-seltzer Pain Relief

Medique Medi-seltzer Pain Relief
SPL v2
SPL
SPL Set ID 3d593dee-b932-b611-e063-6294a90ad3b7
Route
ORAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: L421 Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-17

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

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

Indications and Usage

Uses

  • for the temporary relief of minor aches and pains due to:
  • headache
  • muscle pain
  • backache
  • toothache
  • menstrual pain
  • colds
  • minor arthritis pain
  • temporarily reduces fever
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 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 of age:

Consult a doctor

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
  • an allergic reaction occurs. Seek medical help right away
  • pain lasts for more than 10 days or gets worse
  • fever gets worse or lasts more than 3 days
  • new symptoms appear
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
Section 50567-7

When using this product do not take exceed recommended dosage

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis
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 have asthma
  • you have a sodium-restricted diet
Section 50570-1

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
Section 51727-6

Inactive ingredients : anhydrous citric acid, sodium bicarbonate

Section 51945-4

Medique®

Medi-Seltzer

Pain Relief

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

36 Tablets

(18 x 2)

Tamper Evident Unit Dose Packets

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 at 20 weeks or later in 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

Purpose

Pain Reliever / Fever Reducer

Section 55106-9

Active Ingredients (in each effervescent tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

  • each tablet contains: Sodium 524mg
  • store at room temperature 59º-86º F (15º-30º C) avoid excessive heat.
  • tamper evident sealed packets
  • do not use any opened or torn packets

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the temporary relief of minor aches and pains due to:
  • headache
  • muscle pain
  • backache
  • toothache
  • menstrual pain
  • colds
  • minor arthritis pain
  • temporarily reduces fever
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 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 of age:

Consult a doctor

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

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

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
  • an allergic reaction occurs. Seek medical help right away
  • pain lasts for more than 10 days or gets worse
  • fever gets worse or lasts more than 3 days
  • new symptoms appear
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
Section 50567-7 (50567-7)

When using this product do not take exceed recommended dosage

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis
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 have asthma
  • you have a sodium-restricted diet
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients : anhydrous citric acid, sodium bicarbonate

Section 51945-4 (51945-4)

Medique®

Medi-Seltzer

Pain Relief

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

36 Tablets

(18 x 2)

Tamper Evident Unit Dose Packets

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 at 20 weeks or later in 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)

Purpose

Pain Reliever / Fever Reducer

Section 55106-9 (55106-9)

Active Ingredients (in each effervescent tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

  • each tablet contains: Sodium 524mg
  • store at room temperature 59º-86º F (15º-30º C) avoid excessive heat.
  • tamper evident sealed packets
  • do not use any opened or torn packets

Advanced Ingredient Data


Raw Label Data

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