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antacid

Rij Pharmaceutical Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 5 mL = 1 teaspoonful)

Aluminum hydroxide (Equi. To Dried Gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Purpose

Antacid

Antigas

antacid Uses

relieves

  • •heartburn
  • •acid indigestion
  • •sour stomach
  • •associated symptoms of gas and upset stomach
  • •overindulgence of food and drink

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

taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

  • symptoms last for more than 2 weeks

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • shake well before each use
  • •Adults/children 12 years and older, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
  • •do not take more than 12 teaspoonsful in 24
  • • do not use the maximum dosage for more than 2 weeks
  • •children under 12 years: consult a physician

antacid Other information

  • •TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
  • •Store at room temperature 15º - 30ºC (59º - 86ºF)
  • •keep tightly closed
  • •protect from freezing
  • •each teaspoon (5 mL) contains: magnesium 83 mg
  • •each teaspoon (5 mL) contains: sodium 1 mg
  • •does not meet USP requirements for preservative effectiveness

Inactive ingredients

flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, water and xanthan gum

Principal Display Panel

antacid

Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53807-126
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aluminum hydroxide 200 mg
magnesium hydroxide MAGNESIUM CATION 200 mg
DIMETHICONE 20 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
BUTYLPARABEN
SACCHARIN
SODIUM HYPOCHLORITE
sorbitol
PROPYLPARABEN
water
XANTHAN GUM
LEMON OIL

Product Characteristics

Color
WHITE (opaque)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53807-126-12 355 in 1 BOTTLE
2 NDC:53807-126-28 3785 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part332 1999-03-16


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Be sure to consult your doctor before taking any medication!
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