Search by Drug Name or NDC

NDC 00536-1185-83 rugby almacone 400; 40; 400 mg/10mL; mg/10mL; mg/10mL Details

rugby almacone 400; 40; 400 mg/10mL; mg/10mL; mg/10mL

rugby almacone is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. 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: 00536-1185-83
Last Updated: 11/30/2022
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: 00536-1185-83
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00536-1185
Product ID	0536-1185_7f06d5b8-e781-416a-bcec-44d9650cac0c
Associated GPIs	48991003101810
GCN Sequence Number	002701
GCN Sequence Number Description	mag hydrox/aluminum hyd/simeth ORAL SUSP 200-200-20 ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	63910
HICL Sequence Number	001168
HICL Sequence Number Description	MAGNESIUM HYDROXIDE/ALUMINUM HYDROXIDE/SIMETHICONE
Brand/Generic	Brand
Proprietary Name	rugby almacone
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum hydroxide, Magnesium hydroxide, Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	400; 40; 400
Active Ingredient Units	mg/10mL; mg/10mL; mg/10mL
Substance Name	ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Labeler Name	Rugby Laboratories
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	2024-12-31

Package

Package Images

NDC 00536-1185-83 (00536118583)

Pricing Information
NDC Package Code	0536-1185-83
Billing NDC	00536118583
Package	355 mL in 1 BOTTLE (0536-1185-83)
Marketing Start Date	2018-12-19
NDC Exclude Flag	N
Price Per Unit	0.00773
Pricing Unit	ML
Effective Date	2022-03-23
NDC Description	ALMACONE SUSPENSION
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2022-03-30

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 7f06d5b8-e781-416a-bcec-44d9650cac0c Details

Active ingredients (in each 10 mL)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purposes

Antacid

Antigas

Uses

relieves

•: heartburn
•: acid indigestion
•: sour stomach
•: upset stomach due to these symptoms
•: pressure and bloating commonly 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

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

When using this product

do not exceed 120 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•: shake well before use
•: measure with dosing cup provided
•: adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
•: do not take more than 120 mL in any 24 hour period
•: do not use the maximum dosage for more than 2 weeks
•: children under 12 years: ask a doctor
•: mL = milliliter

Other information

•: each 10 mL contains: magnesium 175 mg
•: does not meet USP requirements for preservative effectiveness
•: store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

1-800-645-2158

Principal Display Panel

Regular Strength

Almacone®

Aluminum Hydroxide

Magnesium Hydroxide, Simethicone

ANTACID

ANTIGAS

VERY LOW SODIUM

12 fl oz (355 mL)

ALCOHOL 0.2%

INGREDIENTS AND APPEARANCE

RUGBY ALMACONE

aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1185
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 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PEPPERMINT OIL (UNII: AV092KU4JH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1185-83	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	12/19/2018

Labeler - Rugby Laboratories (079246066)

Revised: 1/2019

Document Id: 7f06d5b8-e781-416a-bcec-44d9650cac0c

Set id: 7f06d5b8-e781-416a-bcec-44d9650cac0c

Version: 1

Effective Time: 20190107