Medique Medi Seltzer Tablet, Effervescent
FDA Label NDC 47682-135

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medique Medi Seltzer (NDC 47682-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • blisters
  • 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

      • Adults and children 12 years and over (up 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.

Active Ingredient (In Each Tablet)

Aspirin 325mg ( NSAID*)

Citric Acid 1000mg

Sodium bicarbonate (heat-treated) 1916mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever / Fever Reducer

Antacid

Antacid

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

Do Not Use

  • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • right before or after heart surgery
  • if you are taking a prescription drug for gout, diabetes or arthritis

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 reached age 60 or older
  • you are on a sodium restricted diet

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

    • When using this product do not exceed recommended dosage.

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

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

Directions

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

Other Information

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

Inactive Ingredients

none

135B Medique Medi-Seltzer Label

Medique®

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Medi-Seltzer

Effervescent Antacid/Pain Reliever

Pull to Open

Aches, Fever ● Aspirin (NSAID) 325 mg

Antacid ● Citric Acid 1000 mg Sodium Bicarbonate 1916mg

36 Tablets

(18 x 2)

Tamper Evident Unit Dose Packets

* Please review the disclaimer below.