Label: MEDIQUE MEDI SELTZER- aspirin, citric acid, sodium bicarbonate tablet, effervescent
- NDC Code(s): 47682-135-20, 47682-135-24, 47682-135-60
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 18, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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
- you experience any of the following signs of stomach bleeding:
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & 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 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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Medique Medi-Seltzer Label
-
INGREDIENTS AND APPEARANCE
MEDIQUE MEDI SELTZER
aspirin, citric acid, sodium bicarbonate tablet, effervescentProduct 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 Drug M013 12/30/2008 Labeler - Unifirst First Aid Corporation (832947092)