MEDIQUE MEDI SELTZER- aspirin, citric acid, sodium bicarbonate tablet, effervescent

Medique Medi Seltzer by

Drug Labeling and Warnings

Medique Medi Seltzer by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) 325mg

Citric Acid

Sodium bicarbonate (heat-treated) 1916mg

*nonsteriodal 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

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 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

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

Medique®

Collect MediBucks

See inside flap for more details

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 1916mg

72 Tablets

(36 x 2)

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

MEDIQUE MEDI SELTZER 
aspirin, citric acid, sodium bicarbonate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-135
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1916 mg

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	25mm
Flavor		Imprint Code	L421
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-135-20	18 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-135-24	36 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-135-60	300 in 1 BOX	12/30/2008
3		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)