Topco Regular Strength Antacid Mint

Topco Regular Strength Antacid Mint
SPL v2
SPL
SPL Set ID 59c16c09-c23d-4a37-8460-d6c00a268ed5
Route
ORAL
Published
Effective Date 2024-12-26
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (400 mg) Magnesium Cation (40 mg) Dimethicone
Inactive Ingredients
Alcohol Glycerin Hydroxyethyl Cellulose, Unspecified Methylparaben Propylene Glycol Propylparaben Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

Purpose

Antacid Antacid Antigas


Medication Information

Purpose

Antacid

Antacid

Antigas

Description

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

Use(s)

relieves:



  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach and gas associated with these symptoms 
Warnings

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Directions
  • shake well before use
  • adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor
  • children under 12 years: consult a doctor
  • mL = milliliter
Other Information
  • each 10 mL contains: magnesium 170 mg, sodium 5 mg
  • store at 20ºC-25ºC (68º-77ºF)
  • do not freeze
Inactive Ingredients

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Principal Display Panel

Topcare Health

NDC 36800-582-40



REGULAR STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS



FAST RELIEF

  • Heartburn
  • Acid Indigestion
  • Pressure
  • Bloating (Gas)

 

ALCOHOL 0.4% v/v



12 FL OZ (355 mL)

MINT FLAVOR











Stop Use and Ask Doctor

if symptoms last more than two weeks

Keep Out of Reach of Children

.

Active Ingredients (in Each 10 Ml )

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

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.

Structured Label Content

Use(s) (USE(S))

relieves:



  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach and gas associated with these symptoms 
Purpose (PURPOSE)

Antacid

Antacid

Antigas

Warnings (WARNINGS)

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

Directions (DIRECTIONS)
  • shake well before use
  • adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor
  • children under 12 years: consult a doctor
  • mL = milliliter
Other Information (OTHER INFORMATION)
  • each 10 mL contains: magnesium 170 mg, sodium 5 mg
  • store at 20ºC-25ºC (68º-77ºF)
  • do not freeze
Inactive Ingredients (INACTIVE INGREDIENTS)

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Topcare Health

NDC 36800-582-40



REGULAR STRENGTH

Antacid

Advanced

ANTACID & ANTIGAS



FAST RELIEF

  • Heartburn
  • Acid Indigestion
  • Pressure
  • Bloating (Gas)

 

ALCOHOL 0.4% v/v



12 FL OZ (355 mL)

MINT FLAVOR











Stop Use and Ask Doctor (STOP USE AND ASK DOCTOR)

if symptoms last more than two weeks

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

.

Active Ingredients (in Each 10 Ml ) (ACTIVE INGREDIENTS (in each 10 mL ))

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)
  • kidney disease
  • a magnesium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are  (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE )
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)