EXTRA STRENGTH HEARTBURN RELIEF- aluminum hydroxide and magnesium carbonate suspension

EXTRA STRENGTH HEARTBURN RELIEF by

Drug Labeling and Warnings

EXTRA STRENGTH HEARTBURN RELIEF by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 254 mg
Magnesium carbonate 237.5 mg

Purpose

Antacid

Uses

relieves

• heartburn
• sour stomach
• acid indigestion
• upset stomach associated with these symptoms
  

Warnings

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

• laxative effect may occur
• do not use maximum dosage for more than 2 weeks
• do not take more than 16 teaspoonfuls in 24 hours

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.In case of overdose, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well before use
• adults and children 12 years and older take 2-4 teaspoonsful four times a day or as directed by a doctor
• children under 12 years: consult a doctor
• take after meals and at bedtime
• dispense product only by spoon or other measuring device

Other information

• each 5 mL teaspoonful contains: magnesium 70 mg, sodium 16 mg
• store at room temperature
• protect from freezing
• keep tightly closed
• TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is broken or missing.

Inactive ingredients

benzyl alcohol, edetate disodium, flavor, glycerin, purified water, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, xanthan gum

Questions or comments?

1-800-540-3765

package Label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HEARTBURN RELIEF 
aluminum hydroxide and magnesium carbonate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0363
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	254 mg  in 5 mL
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	237.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0363-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/01/2019

Labeler - CARDINAL HEALTH (097537435)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(70000-0363)