OTC Medication Information: Antacid Antigas Maximum Strength

ANTACID ANTIGAS MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide and dimethicone liquid
Family Dollar (FAMILY WELLNESS)

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 ingredient (in each 10 mL)

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

Magnesium Hydroxide 800 mg

Simethicone 80 mg

Purpose

Antacid

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
  • overindulgence in food and drink

Warnings

Do not take

more than 60 mL in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physican

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.

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.

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

Directions

• shake well before using
• mL = milliliter
• do not take more than 60 mL in 24 hours or use the maximum dosage for more than 2 weeks
• measure only with dosing cup provided. Do not use any other dosing device
• keep dosing cup with product
• adults and children12 years and older: take 10-20 mL as needed, between or after meals, at bedtime, or as directed by a doctor
• children under 12 years of age: do not use

Other information

• each 10 mL contains: magnesium 335 mg, sodium 10 mg
• store between 20-25°C (68-77°F).Avoid freezing

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN MYLANTA® MAXIMUM STRENGTH*

MAXIMUM STRENGTH

Antacid & Anti-gas Relief

Multi-Symptom Relief

Aluminum Hydroxide — Antacid

Magnesium Hydroxide — Antacid

Simethicone — Antigas

For Fast Relief of:

• Heartburn
• Acid Indigestion
• Pressure
• Bloating

Alcohol-Free

Sugar-Free

Paraben-Free

ORIGINAL FLAVOR

^* This product is not manufactured or distributed by McNeil Consumer Pharmaceuticals Co., distributor of Mylanta® Maximum Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD.MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS Maximum Strength Antacid & Antigas Relief

ANTACID ANTIGAS MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-528 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) MAGNESIUM HYDROXIDE 800 mg in 10 mL DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg in 10 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN MICROCRYSTALLINE CELLULOSE WATER SODIUM CARBONATE SORBITOL SUCRALOSE XANTHAN GUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55319-528-12 355 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/30/2018 06/30/2025

Labeler — Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 10/2022 Family Dollar (FAMILY WELLNESS)