Harris Teeter Antacid Maximum Strength: Package Insert and Label Information

HARRIS TEETER ANTACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide and dimethicone suspension
Harris Teeter, LLC

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 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg

Magnesium hydroxide 800 mg

Simethicone 80 mg

Purpose

Antacid

Antigas

Uses

for the relief of

acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms
pressure and bloating commonly 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

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not take more than 40 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Keep out of reach of children.

Directions

shake well before using
only use the dose cup provided
adults and children 12 years and older: take 10 mL to 20 mL two times a day or as directed by a physician
do not take more than 40 mL in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years: consult a physician

Other information

each 10 mL contains: magnesium 350 mg and sodium 3 mg
does not meet USP requirements for preservative effectiveness
store at 20-25°C (68-77°F)
protect from freezing

Inactive ingredients

butylparaben, flavor, glycerin, hydroxyethyl cellulose, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

MAXIMUM STRENGTH ANTACID

Antacid & Antigas

Heartburn & Acid Indigestion

Pressure & Bloating

Cherry Flavored Liquid

ALCOHOL 0.1%

12 FL OZ (355 mL)

antacid image
(click image for full-size original)
HARRIS TEETER ANTACID MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69256-588
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 800 mg in 10 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE 800 mg in 10 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
GLYCERIN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SORBITOL
SILICON DIOXIDE
Product Characteristics
Color WHITE (opaque) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69256-588-40 355 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 04/03/2015
Labeler — Harris Teeter, LLC (048463103)

Revised: 07/2019 Harris Teeter, LLC

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