Label: CYDECTIN- moxidectin liquid
- NDC Code(s): 58198-0029-1, 58198-0029-2
- Packager: Elanco US Inc.
- Category: OTC ANIMAL DRUG LABEL
Drug Label Information
Updated January 16, 2024
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- SPL UNCLASSIFIED SECTION
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PRODUCT DESCRIPTION:
CYDECTIN Oral Drench for Sheep is a ready-to-use solution containing 0.1% moxidectin. Moxidectin is an endectocide in the milbemycin chemical class which shares the distinctive mode of action characteristic of macrocyclic lactones. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite.
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INDICATIONS:
CYDECTIN Oral Drench for Sheep, when administered at the recommended dose level of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight, is effective in the treatment and control of adult and larval (L4) stages of the following internal parasites of sheep:
Parasites
Haemonchus contortus - Adult and L4 Cooperia oncophora - Adult and L4
Teladorsagia circumcincta - Adult and L4 Oesophagostomum columbianum - Adult and L4
Teladorsagia trifurcata - Adult and L4 Oesophagostomum venulosum - Adult and L4
Trichostrongylus axei - Adult and L4 Nematodirus battus - Adult and L4
Trichostrongylus colubriformis - Adult and L4 Nematodirus filicollis - Adult and L4
Trichostrongylus vitrinus - Adult and L4 Nematodirus spathiger - Adult and L4
Cooperia curticei - Adult and L4 -
ADMINISTRATION:
CYDECTIN Oral Drench is ready-to-use. Administer 1 mL per 11 lb (1 mL per 5 kg) body weight into the mouth of the sheep, using any standard drenching equipment. Check dose rates and equipment before drenching. Do not overdose. Do not mix with any other products before administration. Avoid contaminating the drench solution.
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DOSAGE:
The recommended rate of administration for CYDECTIN Oral Drench for Sheep is 1 mL per 11 lb (5kg) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. The table below will assist in the calculation of the appropriate volume of drench in 1.0 mL increments and it must be administered based on the weight of animal being treated.
Body Weight
Dose
Body Weight
Dose
Body Weight
Dose
11 lb
5 kg
1 mL
66 lb
30 kg
6 mL
121 lb
55 kg
11 mL
22 lb
10 kg
2 mL
77 lb
35 kg
7 mL
132 lb
60 kg
12 mL
33 lb
15 kg
3 mL
88 lb
40 kg
8 mL
143 lb
65 kg
13 mL
44 lb
20 kg
4 mL
99 lb
45 kg
9 mL
154 lb
70 kg
14 mL
55 lb
25 kg
5 mL
110 lb
50 kg
10 mL
165 lb
75 kg
15 mL
Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.
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HUMAN WARNINGS:
Not for use in humans. Keep this and all drugs out of the reach of children.
For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 1-800-428-4441.
To obtain a copy of the safety data sheet (SDS) which provides more detailed occupational safety information or to report adverse reactions attributable to exposure to this product, call 1-800-428-4441.
- RESIDUE WARNINGS:
- ENVIRONMENTAL WARNINGS:
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ANIMAL SAFETY WARNINGS:
CYDECTIN Oral Drench for Sheep has been formulated specifically for oral use in sheep and should not be given by any other route of administration. Do not use in sick, debilitated, or underweight animals. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.
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OTHER WARNINGS:
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- Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
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- Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.
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- Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
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- A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.
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- Macrocyclic lactones provide prolonged drug exposure that may increase selection pressure for resistant parasites. This effect may be more pronounced in extended-release formulations.
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ANIMAL SAFETY:
A well-controlled U.S. study has demonstrated an adequate margin of safety to allow treatment of sheep four months of age and older with CYDECTIN Oral Drench. In this study no signs of toxicity were seen in sheep given up to 5 times the recommended dose. Reproductive safety studies evaluating the use of CYDECTIN Oral Drench in breeding ewes and rams have not been conducted in the U.S.
- STORAGE:
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DISPOSAL:
Do not contaminate water by direct application or by improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.
Manufactured for: CYDECTIN, Elanco and the diagonal bar logo
Elanco US Inc. are trademarks of Elanco or its affiliates.
Greenfield, IN 46140 U.S.A © 2022 Elanco or its affiliates.
Made in China Restricted Drug (CA) - Use Only As Directed
Made in ItalyElancoTM
YL600404X
YL600405X
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Principal Display Panel - Bottle Label
CYDECTINTM
(moxidectin)Oral Drench for Sheep
AntiparasiticContents 1 L
(33.81 oz)Contains 1 mg moxidectin/mL
For Treatment and Control of Infections Due to Internal Parasites of Sheep.
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Approved by FDA under NADA # 141-247.
CYDECTINTM
(moxidectin)Oral Drench for Sheep
AntiparasiticContents 4 L
(1.06 Gallons)Contains 1 mg moxidectin/mL
For Treatment and Control of Infections Due to Internal Parasites of Sheep.
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.Approved by FDA under NADA # 141-247.
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INGREDIENTS AND APPEARANCE
CYDECTIN
moxidectin liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0029 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength moxidectin (UNII: NGU5H31YO9) (moxidectin - UNII:NGU5H31YO9) moxidectin 1 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0029-1 1000 mL in 1 BOTTLE 2 NDC:58198-0029-2 4000 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141247 07/01/2017 Labeler - Elanco US Inc. (966985624)