aluminum hydroxide, magnesium hydroxide, simethicone description, usages, side effects, indications, overdosage, supplying and lots more!

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aluminum hydroxide, magnesium hydroxide, simethicone

LLC Federal Solutions




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each 5 mL teaspoonful)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Purpose

Antacid

Antacid

Antigas

Uses

Uses

For the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • the symptoms of gas associated with acid indigestion, heartburn, and sour stomach

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.

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 this and all drugs out of reach of children.

When using this product you may get constipated

Directions

  • shake well before use
  • do not take more than 8 teaspoonfuls in 24 hours
  • do not use the maximum dosage for more than 2 weeks
  • dosage: adults and children 12 years and older: 2 to 4 teaspoonfuls two times a day or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 1 mg
  • store at room temperature
  • keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, caramel, color, carboxymethylcellulose sodium, D&C yellow #10, flavor, purified water, saccharin sodium, sorbitol solution

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801

Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-725-30
DELIVERS 30 mL CONTAINING:
ALUMINUM HYDROXIDE 2400 mg
MAGNESIUM HYDROXIDE 2400 mg
SIMETHICONE 240 mg
(MINTOX)
MAXIMUM STRENGTH
ORAL SUSPENSION
ANTACID / ANTIGAS
SHAKE WELL BEFORE USE
LEMON CREME
Exp: 00/00/00   Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

aluminum hydroxide, magnesium hydroxide, simethicone

aluminum hydroxide, magnesium hydroxide, simethicone

aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:24451-725(NDC:0904-5725)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aluminum hydroxide 400 mg
magnesium hydroxide MAGNESIUM CATION 400 mg
DIMETHICONE 40 mg

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
BUTYLPARABEN
CARAMEL
CARBOXYMETHYLCELLULOSE SODIUM
D&C YELLOW NO. 10
water
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 CUP, UNIT-DOSE
2 NDC:24451-725-30 100 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part331 2013-08-12


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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