Medique Medi Seltzer

Medique Medi Seltzer

Drug Labeling and Warnings

Drug Details

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MEDIQUE MEDI SELTZER- aspirin, citric acid, sodium bicarbonate tablet, effervescent 
Unifirst First Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Medique Medi Seltzer

Drug Facts

Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg ( NSAID*)

Citric Acid 1000mg

Sodium bicarbonate (heat-treated) 1916mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / Feverr 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

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

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

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

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

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.

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

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.

Other information

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

Inactive ingredients

none

Questions or comments?

1-800-634-7680

Medique Medi-Seltzer Label

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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

72 Tablets

(36 x 2)

Tamper Evident Unit Dose Packets

Medique Mediseltzer

MEDIQUE MEDI SELTZER 
aspirin, citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 47682-135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size25mm
FlavorImprint Code L421
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 47682-135-2018 in 1 BOX12/30/2008
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC: 47682-135-2436 in 1 BOX12/30/2008
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC: 47682-135-60300 in 1 BOX12/30/2008
32 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/30/2008
Labeler - Unifirst First Aid Corporation (832947092)

Revised: 4/2019
 
Unifirst First Aid Corporation


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