OTC Medication Information: Antacid Antigas Regular Strength

ANTACID ANTIGAS REGULAR 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) 400 mg

Magnesium Hydroxide 400 mg

Simethicone 40 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 120 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 180 mg, potassium 5 mg sodium 4 mg
  • store between 20-25°C (68-77°F).Avoid freezing

Inactive ingredients

benzyl alcohol, carboxymethylcellulose sodium, flavor, FD&C red #40, glycerin, microcrystalline cellulose, potassium citrate, propylene glycol, purified water, sodium saccharin,, sorbitol, 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® REGULAR STRENGTH*

REGULAR 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

Oral Suspension

Alcohol-Free

CHERRY FLAVOR

FL OZ (mL)

†† This product is not manufactured or distributed by McNeil Consumer Pharmaceuticals Co., distributor of Mylanta® Regular 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

Aluminum Hydroxide 400 mg, Magnesium Hydroxide 400 mg, Simethicone 40 mg
(click image for full-size original)

FAMILY WELLNESS Regular Strength Antacid & Antigas Relief

ANTACID ANTIGAS REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-755
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 400 mg in 10 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE 400 mg in 10 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE 40 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
MICROCRYSTALLINE CELLULOSE
WATER
POTASSIUM CITRATE
SORBITOL
SACCHARIN SODIUM
XANTHAN GUM
PROPYLENE GLYCOL
FD&C RED NO. 40
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55319-755-12 355 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)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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