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NDC 70518-1973-00 ALMACONE DOUBLE STRENGTH 400; 40; 400 mg/5mL; mg/5mL; mg/5mL Details

ALMACONE DOUBLE STRENGTH 400; 40; 400 mg/5mL; mg/5mL; mg/5mL

ALMACONE DOUBLE STRENGTH is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE.

MedlinePlus Drug Summary

Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 70518-1973-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aluminum Hydroxide and Magnesium Hydroxide

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 70518-1973-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	70518-1973
Product ID	70518-1973_da7e9b6c-dad7-620e-e053-2a95a90a15bc
Associated GPIs	48991003101835
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALMACONE DOUBLE STRENGTH
Proprietary Name Suffix	n/a
Non-Proprietary Name	aluminum hydroxide, magnesium hydroxide, dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	400; 40; 400
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Labeler Name	REMEDYREPACK INC.
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-1973-00 (70518197300)

Pricing Information	N/A
NDC Package Code	70518-1973-0
Billing NDC	70518197300
Package	10 CUP, UNIT-DOSE in 1 BOX (70518-1973-0) / 20 mL in 1 CUP, UNIT-DOSE (70518-1973-1)
Marketing Start Date	2019-03-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ac1bb713-6915-4e40-84dc-df0fa1f01fab Details

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

Purposes

Antacid

Antigas

Uses

relieves

heartburn
sour stomach
acid indigestion
symptoms referred to as gas

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 more than 2 weeks

Keep out of reach of children.

Directions

shake well before use
adults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
do not take more than 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years: ask a doctor

Other information

each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
store at room temperature
protect from freezing
keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

1-800-645-2158

PRINCIPAL DISPLAY PANEL

DRUG: ALMACONE DOUBLE STRENGTH

GENERIC: aluminum hydroxide, magnesium hydroxide, dimethicone

DOSAGE: SUSPENSION

ADMINSTRATION: ORAL

NDC: 70518-1973-0

NDC: 70518-1973-1

FLAVOR: LEMON

PACKAGING: 20 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

MAGNESIUM HYDROXIDE 400mg in 5mL
DIMETHICONE 40mg in 5mL
ALUMINUM HYDROXIDE 400mg in 5mL

INACTIVE INGREDIENT(S):

BENZYL ALCOHOL
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
PROPYLPARABEN
WATER
SACCHARIN SODIUM
SORBITOL

INGREDIENTS AND APPEARANCE

ALMACONE DOUBLE STRENGTH

aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-1973(NDC:0536-0015)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-1973-0	10 in 1 BOX	03/21/2019
1	NDC:70518-1973-1	20 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/21/2019

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2022

Document Id: da7e9b6c-dad7-620e-e053-2a95a90a15bc

Set id: ac1bb713-6915-4e40-84dc-df0fa1f01fab

Version: 6

Effective Time: 20220318