ALKA-SELTZER GOLD tablet, effervescent

Drug Facts

Drug Facts
Active Ingredients

Anhydrous citric acid 1000 mg.................................………Antacid

Potassium bicarbonate 344 mg.…..………………….……..Antacid

Sodium bicarbonate (heat-treated) 1050 mg………………Antacid
Purpose

Antacid
INDICATIONS & USAGE

Uses for the relief of

● heartburn ● acid indigestion ● sour stomach
Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- kidney disease
- a potassium or 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.
When using this product

When using this product do not exceed recommended dosage
Stop use and ask a doctor if

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks
PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children

Keep out of reach of children.

Directions

● fully dissolve tablets in 4 ounces of water before taking

adults and children 12 years and over	2 tablets every 4 hours as needed, or asdirected by a doctor	do not exceed8 tablets in 24 hours
adults 60 years and over	2 tablets every 4 hours as needed, or as directed by a doctor	do not exceed 6 tablets in 24 hours
children under 12 years	1 tablet every 4 hours as needed, or as directed by a doctor	do not exceed 4 tablets in 24 hours

Other information

● each tablet contains: potassium 135 mg

● each tablet contains: sodium 309 mg

● store at room temperature. Avoid excessive heat.

● this product does not contain aspirin

● Alka-Seltzer Gold in water contains principally the

antacids sodium citrate and potassium citrate
Inactive ingredients

Inactive ingredients magnesium stearate, mannitol
Questions or comments

Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
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
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALKA-SELTZER GOLD
alka-seltzer gold tablet, effervescent

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	344 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	1050 mg

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0280-4100-63	18 in 1 CARTON	11/19/2014
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	11/19/2014

Labeler - Bayer HealthCare LLC. (112117283)

Alka-Seltzer Gold by