MedPath

Antacid

Rugby Regular Strength Antacid Liquid

Approved
Approval ID

a96496ff-4b35-4ebe-a6e4-bcfa48fb1341

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

aluminum hydroxide, magnesium hydroxide, simethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68788-8506
Application Numberpart331
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide, magnesium hydroxide, simethicone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (13)

ALUMINUM HYDROXIDEActive
Quantity: 400 mg in 10 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 400 mg in 10 mL
Code: NBZ3QY004S
Classification: ACTIB
DIMETHICONE, UNSPECIFIEDActive
Quantity: 40 mg in 10 mL
Code: 92RU3N3Y1O
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2025

PRINCIPAL DISPLAY PANEL

Rugby

NDC 68788-8506-3

Regular Strength
** Antacid Liquid**
Aluminum hydroxide, 400 mg
Magnesium hydroxide, 400 mg
Simethicone, 40 mg

** Antacid and Antigas**
Original Flavor


Relief of:

Heartburn

Acid Indigestion

Sour Stomach

Pressure & Bloating


12 FL OZ (355 mL)
Alcohol content 0.2% v/v

Regular Strength Antacid Liquid

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/17/2025

USE(S)

relieves:

acid indigestion

heartburn

sour stomach

upset stomach and gas associated with these symptoms 

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/17/2025

ACTIVE INGREDIENTS (in each 10 mL )

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/17/2025

PURPOSE

Antacid
Antacid
Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 9/17/2025

WARNINGS

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/17/2025

ASK A DOCTOR BEFORE USE IF YOU HAVE

kidney disease

a magnesium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 9/17/2025

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/17/2025

STOP USE AND ASK DOCTOR

if symptoms last more than two weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/17/2025

KEEP OUT OF REACH OF CHILDREN

.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/17/2025

DIRECTIONS

**shake well before use**

mL = milliliter

adults and children 12 years and older: take 10 mL to 20 mL four times a day, or as directed by a doctor

children under 12 years: consult a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/17/2025

OTHER INFORMATION

**each 10 mL contains:** magnesium 170 mg, sodium 5 mg

store at controlled room temperature 20ºC-25ºC (68º-77ºF)

do not freeze

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/17/2025

INACTIVE INGREDIENTS

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

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