Label: ALKA-SELTZER GOLD tablet, effervescent
- NDC Code(s): 0280-4100-63
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
- Do Not Use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- 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
- Inactive ingredients
- Questions or comments
-
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, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-4100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-4100-63 18 in 1 CARTON 11/19/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M001 11/19/2014 Labeler - Bayer HealthCare LLC. (112117283)
