GERI-LANTA ANTACID ANTIGAS: Package Insert and Label Information

GERI-LANTA ANTACID ANTIGAS- aluminum hydroxide, magnesium hydroxide and dimethicone liquid
ATLANTIC BIOLOGICALS CORP.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

Purposes

Antacid
Antigas

Uses

relieves

• heartburn
• sour stomach
• acid indigestion
• the symptoms referred to as gas

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 out of 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 24 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: magnesium 85 mg, sodium 3 mg
• store at room temperature
• protect from freezing
• keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

1-800-540-3765

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

package Label

GERI-LANTA ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0630(NDC:57896-629) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 200 mg in 5 mL MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 200 mg in 5 mL DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg in 5 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL BUTYLPARABEN HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) PROPYLPARABEN WATER SACCHARIN SODIUM (SACCHARIN) SORBITOL

Product Characteristics Color Score Shape Size Flavor LEMON (citrus mint) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:17856-0630-1 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE 1 30 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0630-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/01/2000

Labeler — ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Operations
ATLANTIC BIOLOGICALS CORP.		047437707	relabel (17856-0630), repack (17856-0630)

Revised: 12/2020 ATLANTIC BIOLOGICALS CORP.