HeifermaX 500

Manufacturer
Elanco Animal Health Co | Virbac Corporation | CRYSTAL PHARMA SAU
Effective date
2018-10-30
Label type
OTC ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:48:07

Label at a glance#

ProductHeifermaX 500
Active ingredientmelengestrol acetate
Label structure5 sections

Dosage and administration

HEIFERMAX ® 500 should be thoroughly mixed in liquid Type C medicated feed which must be fed at 0.5 to 2.0 pounds per head daily to provide 0.25 to 0.5 mg of melengestrol acetate per head per day. Average daily intakes approximating the middle of this range provide the most optimal and economical improvements in rate of weight gain and feed utilization. Constant daily intakes of 0.35 to 0.50 mg per head per day gi...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Elanco™

HeifermaX® 500 (melengestrol acetate)

Liquid Premix

(Type A Medicated Article)

Heifers Fed in Confinement for Slaughter: For Increased Rate of Weight Gain,
Improved Feed Efficiency, and Suppression of Estrus (Heat).

Heifers Intended for Breeding: For Suppression of Estrus (Heat).

Not for human use.

DIRECTIONS FOR USE:

INDICATIONS & USAGE SECTION

Heifers Fed in Confinement for Slaughter:

SPL UNCLASSIFIED SECTION

HEIFERMAX® 500 should be thoroughly mixed in liquid Type C medicated feed which must be fed at 0.5 to 2.0 pounds per head daily to provide 0.25 to 0.5 mg of melengestrol acetate per head per day. Average daily intakes approximating the middle of this range provide the most optimal and economical improvements in rate of weight gain and feed utilization. Constant daily intakes of 0.35 to 0.50 mg per head per day give a high degree of estrus suppression. Levels of 0.25 to 0.35 mg provide a lower but still effective degree of estrus suppression.

Heifers Intended for Breeding:

SPL UNCLASSIFIED SECTION

HEIFERMAX® 500 should be thoroughly mixed in the supplement to provide 0.5 mg of melengestrol acetate per head per day.

Heifers Fed in Confinement for Slaughter:

SPL UNCLASSIFIED SECTION

Withdrawal periods of three to five days or more should be avoided to prevent the possibility that the heifers may come into estrus (heat) at loading time.

Heifers Intended for Breeding:

SPL UNCLASSIFIED SECTION

Do not exceed 24 days of feeding of melengestrol acetate to heifers intended for breeding. A reduced conception rate can be expected if heifers are bred at estruses observed within 1 to 12 days after withdrawal of melengestrol acetate, whereas heifers bred at subsequent observed estruses are expected to have normal conception rates.

Not effective in steers or spayed heifers.

MIXING DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Liquid Type B and C medicated feeds containing melengestrol acetate must have a pH of 4.0 to 8.0 and their labels must bear appropriate mixing directions. Mixing directions for liquid Type B (or C) feeds stored in recirculation tank systems are: “Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily, as directed in this paragraph even when the Type B (or C) feed is not used.” Mixing directions for liquid Type B and C feeds stored in mechanical, air or other agitation-type tank systems are: “Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily, as directed in this paragraph, even when the Type B (or C) feed is not used.”

Intermediate premixes should not be made from HEIFERMAX® 500 except as a part of a continuous mixing operation to make a complete liquid Type B (or C) medicated feed.

Thoroughly mix 0.5 to 4 pounds of HEIFERMAX® 500 per ton of a non-medicated feed to prepare a Type C medicated feed containing 0.25 to 2.0 grams of melengestrol acetate per ton. The following table may be used as a guide in determining the amount of HEIFERMAX® 500 to be added to prepare a ton of Type C medicated feed.



Amount of
Type C Feed Fed
(lb/head/day)


Melengestrol
Acetate
(mg/head/day)
HEIFERMAX® 500 Liquid Premix
Per Ton of Type C Feed
When Added by
Weight (lb)
When Added by
Volume (mL)
0.5 0.25 2.00 876
0.5 0.30 2.40 1051
0.5 0.35 2.80 1226
0.5 0.40 3.20 1402
0.5 0.45 3.60 1577
0.5 0.50 4.00 1752
1.0 0.25 1.00 438
1.0 0.30 1.20 526
1.0 0.35 1.40 613
1.0 0.40 1.60 701
1.0 0.45 1.80 788
1.0 0.50 2.00 876
1.5 0.25 0.66 289
1.5 0.30 0.80 350
1.5 0.35 0.93 407
1.5 0.40 1.07 469
1.5 0.45 1.20 526
1.5 0.50 1.33 582
2.0 0.25 0.50 219
2.0 0.30 0.60 263
2.0 0.35 0.70 307
2.0 0.40 0.80 350
2.0 0.45 0.90 394
2.0 0.50 1.00 438

Type B medicated feed containing 4 to 10 grams melengestrol acetate per ton may be manufactured by thoroughly mixing 8 to 20 lbs of HEIFERMAX® 500 with 1992 to 1980 lbs of non-medicated feed. Labeling for such Type B feed shall contain directions for manufacturing Type C medicated feeds containing 0.25 to 2.0 grams melengestrol acetate per ton (0.125 to 1.0 mg/lb). The Type C medicated feed, containing melengestrol acetate, must be top dressed on grain or roughage or mixed with a complete ration at the rate of 0.5 to 2.0 pounds per head per day.

Good manufacturing practice regulations must be adhered to in manufacturing feeds containing HEIFERMAX® 500.

Restricted Drug — Use only as Directed (California)

Elanco, HeifermaX and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

Distributed by Elanco Animal Health, a Division of Eli Lilly and Company, Indianapolis, IN 46285, USA

To report adverse events, access medical information, or to obtain additional product information, call 1-800-428-4441

ANADA 200-343, Approved by FDA

Principal Display Panel - Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™
HeifermaX® 500
(melengestrol acetate) TM
Liquid Premix
(Type A Medicated Article)
HEIFERS FED IN CONFINEMENT FOR SLAUGHTER:
For increased Rate of Weight Gain, Improved Feed Efficiency, and Suppression of Estrus (Heat).
HEIFERS INTENDED FOR BREEDING:
For Suppression of Estrus (Heat).
Each Pound Contains:
Active Drug Ingredient:
Melengestrol acetate .............................................................500 mg
(as melengestrol acetate and its propylene glycol ketal)
Inactive Ingredient:
Propylene glycol, USP..............................................................99.89%
Precautions: For manufacturing, processing, or repacking. To be mixed with feed prior to animal use.
Use only as directed. Excessive contact with skin should be avoided. Destroy empty container. Do not reuse.
Store at controlled room temperature (20° to 25°C)
ANADA 200-343, Approved by FDA
Net Weight 40 Pounds (18 kg) (4.627 gal [17.5 L]) AF0637 YL086323AMA (V02-09-2012)

image descriptiondtykdhimage descriptiondtykdh

Principal Display Panel - Pail Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elanco™
HeifermaX® 500
(melengestrol acetate) TM
Liquid Premix
(Type A Medicated Article)
Store at controlled room
temperature (20° to 25°C)
Distributed by Elanco Animal Health,
a Division of Eli Lilly and Company,
Indianapolis, IN 46285, USA
1 (40 lb [18 kg]) (4.627 gal [17.5L])
AF0637 SH086323AMX V02-09-2012

image descriptionkklihnimage descriptionkklihn

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
melengestrol acetateACTIVE INGREDIENT4W5HDS39361
melengestrolACTIVE MOIETYBX98J4T6JU1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0986-06370986-0637-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
melengestrol acetate4W5HDS3936ACTIB
propylene glycol6DC9Q167V3IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 81 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.