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

Antacid antigas by

Drug Labeling and Warnings

Antacid antigas by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-528-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	06/30/2018

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)