ANTACID SUPREME- calcium carbonate, magnesium hydroxide suspension

ANTACID SUPREME by

Drug Labeling and Warnings

ANTACID SUPREME by is a Otc medication manufactured, distributed, or labeled by FREDS, INC, GCP Laboratories, GCP LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Calcium carbonate 400 mg
Magnesium hydroxide 135 mg

Purpose

Antacid

Uses

relieves

• heartburn
• sour stomach
• acid indigestion
• upset stomach associated with these symptoms
• overindulgence in food and drink

Warnings

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug.
Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than 2 weeks
If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

Directions

• shake well before use
• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
• do not take more than 18 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
• children under 12 years: ask a doctor
  

Other information

• each 5 mL teaspoonful contains: calcium 160mg, magnesium 55 mg
• refrigerate after opening to preserve freshness and purity
• do not freeze
• keep tightly closed

Inactive ingredients

benzyl alcohol, flavor, hydroxyethylcellulose, purified water, saccharin sodium, simethicone emulsion, sorbic acid, sorbitol solution, xanthan gum

package Label

INGREDIENTS AND APPEARANCE

ANTACID SUPREME 
calcium carbonate, magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-624
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	135 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-624-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	05/01/2012

Labeler - FREDS, INC (005866116)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP LABORATORIES		965480861	manufacture(55315-624) , pack(55315-624)