BROMO SELTZER description, usages, side effects, indications, overdosage, supplying and lots more!

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BROMO SELTZER

Tower Laboratories Ltd
Tower Laboratories Ltd

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (in each effervescent tablet)                                       Purpose

Aspirin 325mg NSAID* .............................................                            Pain Reliever
Citric Acid 1000 mg ...................................................                                   Antacid
Sodium Bicarbonate (heat-treated) 1916 mg ................                                    Antacid

*Nonsteroidal anti-inflammatory drug

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 ealy sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may casue a sever allergic reaction which may include: - hives - facial swelling - asthma (wheezing) - shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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.

Uses

Uses

for the temporary relief of

■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains

■ upset stomach with headache from overindulgence in food or drink

■ pain alone (headaches or body aches and pains)

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 a sodium-restricted diet

 Ask a doctor or pharmacist before use if you are - presently taking a prescription drug.  Antacids may interact with certain prescription drugs. - taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - if overly full from food or drink.  Ask a doctor if sever stomach pain occurs after taking this product.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - 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 - new symptoms occur - redness or swelling is present - ringing in the ears or a loss of hearing occurs

When using this product do not take more than 8 tables (adults) and 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days.

Purpose

Fast Relief of: Indigestion, Upset stomach, Heartburn with headache, Body Aches and Pains.

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 esceed 8 tablets in 24 hours
60 year and over

2 tablets every 4 hours
do not exceed 4 tablets in 24 hours

There are no inactive ingredients.

BROMO SELTZER

BROMO SELTZER

ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET, EFFERVESCENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50201-0421
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE 1916 mg
ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID 1000 mg
aspirin ASPIRIN 325 mg

Product Characteristics

Color Size Imprint Code Shape
white 25 mm L421 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50201-0421-2 20 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-10-01


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Be sure to consult your doctor before taking any medication!
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