ANTACID DOUBLE STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid

antacid double strength by

Drug Labeling and Warnings

antacid double strength by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL) (One teaspoonful)

Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg

Magnesium Hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

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 and children 12 years, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
• do not take more than 12 teaspoonsful in 24 hour period
• do not use the maximum dosage for more than 2 weeks
• children under 12 years: ask a doctor

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 165 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, xanthan gum and water

Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTACID DOUBLE STRENGTH 
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-158
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SACCHARIN (UNII: FST467XS7D)
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)
SORBITOL (UNII: 506T60A25R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
LEMON OIL (UNII: I9GRO824LL)

Product Characteristics
Color	WHITE (opaque)	Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-158-05	148 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999
2	NDC: 53807-158-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	03/16/1999

Labeler - Rij Pharmaceutical Corporation (144679156)

Establishment
Name	Address	ID/FEI	Business Operations
Rij Pharmaceutical Corporation		144679156	manufacture(53807-158)