Bromo Seltzer

Bromo Seltzer

Drug Labeling and Warnings

Drug Details

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BROMO SELTZER- aspirin, sodium bicarbonate, citric acid tablet, effervescent 
Tower Laboratories Ltd

Disclaimer: 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.

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Bromo Seltzer

Active ingredients

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

Purpose

Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever

Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid

Sodium bicarbonate (heat-treated) 1916 mg . . . . . . Antacid

*Nonsteroidal anti-inflammatory drug

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)

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.

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.

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

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.

Stop use and ask 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

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 hrs

■ 60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hrs

Other information

each tablet contains: sodium 524 mg

■ store at room temperature (59° to 86°F)

Inactive ingredients

■ none

Serious side effects associated with the use of this product can be reported to the following address:

Tower Laboratories Ltd.

PO Box 306

8 Industrial Park Rd

Centerbrook, CT 06409

image of carton

BROMO SELTZER 
aspirin, sodium bicarbonate, citric acid tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50201-0421
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) 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; Type 0: Not a Combination Product07/16/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/16/2012
Labeler - Tower Laboratories Ltd (001587203)
Registrant - Tower Laboratories Ltd (869024500)
Establishment
NameAddressID/FEIBusiness Operations
Tower Laboratories Ltd869024500manufacture(50201-0421) , pack(50201-0421) , label(50201-0421)

Revised: 12/2017
 
Tower Laboratories Ltd


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