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  5. Label Information: Medique Medi Seltzer

FDA Label for Medique Medi Seltzer

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. 135B MEDIQUE MEDI-SELTZER LABEL

Medique Medi Seltzer Product Label

The following document was submitted to the FDA by the labeler of this product Unifirst First Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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®

Collect MediBucks

See inside flap for more details

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.