FDA Label for Medique Medi-seltzer Pain Relief

Other

Drug Facts

Otc - Active Ingredient

Active Ingredients (in each effervescent tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain Reliever / Fever Reducer

Indications & Usage

Uses

• for the temporary relief of minor aches and pains due to:
• headache
• muscle pain
• backache
• toothache
• menstrual pain
• colds
• minor arthritis pain
• temporarily reduces fever

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

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 alcoholic drinks every day while using this product
take more or for a longer time than directed

Otc - Do Not Use

Do not use

• if you are allergic to aspirin or any other pain reliever/ fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

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 have asthma
• you have a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

• diabetes
• gout
• arthritis

Otc - When Using

When using this product do not take exceed recommended dosage

Otc - 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
• an allergic reaction occurs. Seek medical help right away
• pain lasts for more than 10 days or gets worse
• fever gets worse or lasts more than 3 days
• new symptoms appear
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

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 years and over:

2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours

Adults 60 years and over:

2 tablets every 4 hours, or as directed by a doctor. Do not exceed 4 tablets in 24 hours

Children under 12 years of age:

Consult a doctor

Other Safety Information

Other information

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

Inactive Ingredient

Inactive ingredients: anhydrous citric acid, sodium bicarbonate

Otc - Questions

Questions or comments? 1-800-634-7680

Package Label.Principal Display Panel

Medique®

Medi-Seltzer

Pain Relief

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 1916 mg

36 Tablets

(18 x 2)

Tamper Evident Unit Dose Packets