Minolira Extended Release (Page 6 of 6)

INSTRUCTIONS FOR USE MINOLIRA (min-oh-li’-rah) (minocycline hydrochloride) extended-release tablets

Read this Instructions for Use before you start using MINOLIRA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Note:

  • Your healthcare provider will tell you how much of MINOLIRA to take and if you will need to break MINOLIRA extended-release tablets based on your weight.
  • MINOLIRA comes in 2 strengths:
    • 105 mg extended-release tablets
    • 135 mg extended-release tablets

The 105 mg MINOLIRA tablets:

  • are marked with an “M” and “1” on one side and is separated by a scored line
  • can be taken whole or may be broken at the scored line to provide two equal halves of 52.5 mg each

How to break your MINOLIRA tablets?

  • Hold the tablet between your thumbs and index fingers close to the scored line.
  • Apply enough pressure to break the tablet at the scored line.
  • Do not break the MINOLIRA tablet in any other way.
    • 105 mg treatment (take whole tablet)
ImageImageImage
top view of whole tabletside view of whole tabletside view of whole tablet with thumbs and index fingers
  • 52.5 mg treatment (take one-half of the tablet)
ImageImageImage
side view of breaking a whole tablet with thumbs and index fingerstop view of a split tabletside view of one-half tablet with a thumb and an index finger

The 135 mg MINOLIRA tablets:

  • are marked with an “M” and “3” on one side and is separated by a scored line
  • can be taken whole or may be broken at the scored line to provide two equal halves of 67.5 mg each

How to break your MINOLIRA tablets?

  • Hold the tablet between your thumbs and index fingers close to the scored line.
  • Apply enough pressure to break the tablet at the scored line.
  • Do not break the MINOLIRA tablet in any other way.
    • 135 mg treatment (take whole tablet)
ImageImageImage
top view of whole tabletside view of whole tabletside view of whole tablet with thumbs and index fingers
  • 67.5 mg treatment (take one-half of the tablet)
ImageImageImage
side view of breaking a whole tablet with thumbs and index fingerstop view of a split tabletside view of one-half tablet with a thumb and an index finger

How should I store MINOLIRA?

  • Store MINOLIRA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep MINOLIRA in the container that it comes in and keep the container tightly closed.
  • Keep MINOLIRA away from light and moisture.

Keep MINOLIRA and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:
EPI Health, LLC
134 Columbus St.
Charleston, SC 29403, USA

Manufactured by:
Dr. Reddy’s Laboratories Limited
FTO-SEZ, Process Unit-01,
Devunipalavalasa Village, Srikakulam (District),
Andhra Pradesh, India.
Pin-:532409

MINOLIRA is a registered trademark of EPI Health, LLC

Item No. MIN-PI-0618/150073673

Issued: 06/2018

PRINCIPAL DISPLAY PANEL — 135 mg Tablet Bottle Label

NDC 71403-102-30
Rx Only

minolira™
(minocycline hydrochloride)
extended-release tablets

135 mg*

*Each tablet contains 135 mg of minocycline
(33.75 mg as immediate release beads and
101.25 mg as extended release beads), equivalent
to 145.8 mg of minocycline hydrochloride.

30 Tablets

EPIHEALTH Advancing Dermatology

PRINCIPAL DISPLAY PANEL -- 135 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 105 mg Tablet Bottle Label

NDC 71403-101-30
Rx Only

minolira™
(minocycline hydrochloride)
extended-release tablets

105 mg*

*Each tablet contains 105 mg of minocycline
(26.25 mg as immediate release beads and 78.75
mg as extended release beads), equivalent to
113.4 mg of minocycline hydrochloride.

30 Tablets

EPIHEALTH Advancing Dermatology

PRINCIPAL DISPLAY PANEL -- 105 mg Tablet Bottle Label
(click image for full-size original)
MINOLIRA EXTENDED RELEASE minocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71403-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Minocycline Hydrochloride (MINOCYCLINE) MINOCYCLINE 135 mg
Inactive Ingredients
Ingredient Name Strength
Isopropyl Alcohol
Sodium Stearyl Fumarate
Talc
MICROCRYSTALLINE CELLULOSE
Hypromellose 2910 (5 Mpa.S)
Polyethylene Glycol 400
Ethylcellulose (10 Mpa.S)
Hypromellose 2910 (15 Mpa.S)
Triethyl Citrate
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Water
Product Characteristics
Color WHITE Score 2 pieces
Shape RECTANGLE Size 20mm
Flavor Imprint Code M3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71403-102-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (71403-102-30)
2 NDC:71403-102-05 1 BOTTLE in 1 CARTON contains a BOTTLE
2 5 TABLET in 1 BOTTLE This package is contained within the CARTON (71403-102-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209269 03/15/2019
MINOLIRA EXTENDED RELEASE minocycline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71403-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Minocycline Hydrochloride (MINOCYCLINE) MINOCYCLINE 105 mg
Inactive Ingredients
Ingredient Name Strength
Isopropyl Alcohol
Sodium Stearyl Fumarate
Talc
MICROCRYSTALLINE CELLULOSE
Hypromellose 2910 (5 Mpa.S)
Polyethylene Glycol 400
Ethylcellulose (10 Mpa.S)
Hypromellose 2910 (15 Mpa.S)
Triethyl Citrate
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Water
Product Characteristics
Color WHITE Score 2 pieces
Shape RECTANGLE Size 19mm
Flavor Imprint Code M1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71403-101-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (71403-101-30)
2 NDC:71403-101-05 1 BOTTLE in 1 CARTON contains a BOTTLE
2 5 TABLET in 1 BOTTLE This package is contained within the CARTON (71403-101-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209269 03/15/2019
Labeler — EPI Health, Inc (080638894)
Establishment
Name Address ID/FEI Operations
EPI Health, Inc. 080638894 MANUFACTURE (71403-102), MANUFACTURE (71403-101)

Revised: 11/2022 EPI Health, Inc

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