Your browser does not support JavaScript! BROMO SELTZER (ASPIRIN, SODIUM BICARBONATE, CITRIC ACID) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

BROMO SELTZER (aspirin, sodium bicarbonate, citric acid) tablet, effervescent
[Tower Laboratories Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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.

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.

image of carton

BROMO SELTZER 
aspirin, sodium bicarbonate, citric acid tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50201-0421
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (BICARBONATE ION) BICARBONATE ION1916 mg
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID1000 mg
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorImprint Code L421
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50201-0421-220 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/01/2012
Labeler - Tower Laboratories Ltd (001587203)
Registrant - Tower Laboratories Ltd (869024500)
Establishment
NameAddressID/FEIBusiness Operations
Tower Laboratories Ltd869024500manufacture(50201-0421)

Revised: 9/2012
 
Tower Laboratories Ltd

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services