BROMO SELTZER- aspirin, sodium bicarbonate, citric acid tablet, effervescent

Bromo Seltzer by

Drug Labeling and Warnings

Bromo Seltzer by is a Otc medication manufactured, distributed, or labeled by Tower Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

(in each tablet)

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

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

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 severe stomach pain occurs after taking this product.

Ask a doctor before use if

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

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

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 a doctor if

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 loss of hearing occurs

If pregnant or breast-feeding,

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

Keep out of reach of children.

OVERDOSAGE

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°-86°F)

Inactive ingredients

■ none

QUESTIONS

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

Tower Laboratories LTD.

P.O. Box 306

8 Industrial Park Rd.

Centerbrook, CT 06409

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROMO SELTZER 
aspirin, sodium bicarbonate, citric acid tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50201-0421
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1916 mg
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor		Imprint Code	L421
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50201-0421-2	20 in 1 CARTON; Type 0: Not a Combination Product	07/16/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	07/16/2012

Labeler - Tower Laboratories Ltd (001587203)

Registrant - Tower Laboratories Ltd (869024500)

Establishment
Name	Address	ID/FEI	Business Operations
Tower Laboratories Ltd		869024500	manufacture(50201-0421) , pack(50201-0421) , label(50201-0421)