HM Medical Clinic

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SDS: Doxycycline Hyclate Capsules, USP
SAFETY DATA SHEET
Identification

Product Identifier:
Doxycycline Hyclate Capsules, USP Synonyms:
Doxycycline hydrochloride hemiethanolate hemihydrate National Drug Code (NDC):
Recommended Use:

Company:
1925 West Field Court, Suite 300 Lake Forest, Illinois 60045 Contact Telephone:
Emergency Phone Number:
CHEMTREC 1-800-424-9300 (U.S. and Canada) Hazard(s) Identification

Physical Hazards:
Not classifiable. Health Hazards:
Not classifiable. Symbol(s):
Signal Word:
Hazard Statement(s):
Precautionary Statement(s):
Hazards Not Otherwise Classified:
Not classifiable.
Supplementary Information:
While this material is not classifiable as hazardous under the OSHA standard, this SDS contains valuable information critical to safe handling and proper use of the product. This SDS should be retained and available for employees and other users of this product. Composition/Information on Ingredients
Chemical Name
Synonyms
Chemical
Molecular
Percentage
6-methyl-1,11-dioxo-, monohydrochloride, compound with ethanol (2:1), monohydrate, [4S-(4alpha, 4a alpha, 5alpha, 5a alpha, 6alpha, 12a alpha)]- *The formula also contains Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate.

SDS: Doxycycline Hyclate Capsules, USP
50 mg gelatin capsule shell contains: FD&C Blue #1, Silicon Dioxide, Sodium Lauryl Sulfate and Titanium
Dioxide.
100 mg gelatin capsule shell contains: FD&C Blue #1, silicon dioxide, Sodium Lauryl Sulfate and Titanium
Dioxide. The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-
Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol and Synthetic Black Iron Oxide.
4.
First Aid Measures

Ingestion:
If a person vomits place them in the recovery position so that vomit will not reenter the mouth and throat. Rinse mouth with water. If swallowed, seek medical advice immediately and show the container or label. Treat symptomatically and supportively. Ensure that medical personnel are aware of the material(s) involved and take precautions to protect themselves.
Eye Contact:
Remove from source of exposure. Flush with copious amounts of water for at least 15 minutes. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Ensure that medical personnel are aware of the material(s) involved and are aware of precautions to protect themselves. Skin Contact:
Remove from source of exposure. Remove and isolate contaminated clothing and shoes. Flush with copious amounts of water for at least 20 minutes. Use soap. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Ensure that medical personnel are aware of the material(s) involved and are aware of precautions to protect themselves.
Inhalation:
Remove from source of exposure. Move individual(s) to fresh air. Give artificial respiration if individual(s) are not breathing and call emergency medical service. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Ensure that medical personnel are aware of the material(s) involved and are aware of precautions to protect themselves.
Protection of First-Aiders:
Use personal protective equipment (see section 8). Signs and Symptoms:
Due to oral doxycycline's virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with monilial overgrowth) in the anogenital region. Hepatotoxicity has been reported rarely. These reactions have been caused by both the oral and parenteral administration of tetracyclines. Rare instances

SDS: Doxycycline Hyclate Capsules, USP
of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class. Most of these patients took medications immediately before going to bed
Medical Conditions Aggravated
by Exposure:

Notes to Physician:
Treat supportively and symptomatically. Firefighting Measures

Suitable Extinguishing Media:
Use extinguishing media for type of surrounding fire. Unsuitable Extinguishing Media:
Specific Hazards Arising from the Chemical:
Hazardous Combustion Products:
No data available. Other Specific Hazards:
Closed containers may explode from the heat of fire.
Special Protective Equipment/
Precautions for Firefighters:
Wear self-contained breathing apparatus and full and protective gear. Accidental Release Measures
Personal Precautions:
Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate personal protective equipment and clothing.
Personal Protective Equipment:
For personal protection see section 8.
Methods for Cleaning Up:
Sweep up or vacuum up spillage and collect in suitable container for disposal. Avoid the generation of dusts during clean-up. Wash spill site.
Environmental Precautions:
Contain material and prevent release to basements, confined spaces, waterways or soil.
Reference to Other Sections:
Refer to Sections 8, 12 and 13 for further information. Handling and Storage
Precautions for Safe Handling:
Handle in accordance with product label and/or product insert information. Handle in accordance with good industrial hygiene and safety practices. Conditions for Safe Storage,
Including Any Incompatibilities:
Store according to label and/or product insert information. Store away from oxidizers, acids, and bases.
Specific End Use:
Pharmaceuticals.

SDS: Doxycycline Hyclate Capsules, USP
Exposure Controls/Personal Protection
Occupational Exposure Guidelines:
Common or Chemical Name
Employee Exposure Limits
Doxycycline Hyclate
Engineering Controls:
Engineering controls should be used as the primary means to control exposures. Respiratory Protection:
Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an effective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134). Eyes Protection:
Safety glasses with side shields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area. Hand Protection:
Chemically compatible gloves are recommended. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic non-latex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy.
Skin Protection:
Wear protective laboratory coat, apron, or disposable garment when working with large quantities. Physical and Chemical Properties
Physical State/Color:
Blue/Blue Opaque capsule. No data available. Odor Threshold:
No data available. No data available. Melting Point:
No data available. Freezing Point:
No data available. Boiling Point:
No data available. Flash Point:
No data available. Evaporation Rate:
No data available. Flammability (solid, gas):
No data available. Flammability Limit - Lower:
No data available. Flammability Limit - Upper:
No data available. Vapor Pressure:
No data available. Vapor Density:
No data available. Relative Density:
No data available. No data available.

SDS: Doxycycline Hyclate Capsules, USP
Partition Coefficient
No data available. Auto-Ignition Temperature:
No data available. Decomposition Temperature:
No data available. Viscosity:
No data available. Stability and Reactivity

Reactivity:
No reactivity hazards known.
Chemical Stability:
Stable under recommended storage conditions.
Possibility of Hazardous Reactions: No dangerous reaction known under conditions of

Conditions to Avoid (e.g., static
discharge, shock, or vibration):

Incompatible Materials:
Oxidizers, acids, bases. Hazardous Decomposition
Products:
NOx. Cl-. Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions. Toxicological Information

Information on the Likely Routes of Exposure:
Inhalation:
May be harmful if inhaled. May cause respiratory tract irritation.
Ingestion:
May harmful if swallowed. Skin Contact:
May be harmful if absorbed through the skin. May cause irritation.
Eye Contact:
May cause eye irritation. Symptoms Related to the Physical,
Chemical and Toxicological
See Section 4. To the best of our knowledge, the chemical, physical and toxicological properties have not been thoroughly investigated. Delayed and Immediate Effects of
Exposure:
No data available. Acute Toxicity:
Compound
Test Type
Doxycycline Hyclate Doxycycline Hyclate Doxycycline Hyclate
Acute Toxicity – Dermal:
No data available. Acute Toxicity – Inhalation:
No data available.

SDS: Doxycycline Hyclate Capsules, USP
No data available. Dermal Irritation:
No data available. Eye Irritation:
No data available. No data available. No data available. Target Organ Effects:
No data available.
Reproductive Effects:
Pregnancy Category D.
Carcinogenicity:
No data available. National Toxicology Program (NTP): Not considered to be a carcinogen. International Agency for Research on Cancer (IARC): Not considered to be a carcinogen. Occupational Safety and Health Administration (OSHA): Not considered to be a carcinogen.
Mutagenicity:
No data available. Aspiration Hazard:
No data available. Ecological Information
Ecotoxicity
Aquatic:
No data available. Terrestrial:
No data available. Persistence and Degradability:
No data available. Bioaccumulative Potential:
No data available. Mobility in Soil:
No data available. Mobility in Environment:
No data available. Other Adverse Effects:
No data available. Disposal Considerations
Dispose of all waste in accordance with Federal, State and Local regulations. Transport Information
UN Number:
UN Proper Shipping Name:
Transport Hazard Class(es):
Packing Group:
Department of Transportation:
Not regulated as a hazardous material.
International Air Transport
Association (IATA):
Not regulated as a dangerous good.
International Maritime Dangerous
Good (IMDG):
Not regulated as a dangerous good.

SDS: Doxycycline Hyclate Capsules, USP
Regulatory Information
US Federal Regulations:
Toxic Substance Control Act
(TSCA):
This product is a drug regulated by the Food and Drug Administration (FDA), and is not regulated by TSCA. CERCLA Hazardous Substance
and Reportable Quantity:
SARA 313:
SARA 302:
State Regulations
New Jersey:
Pennsylvania:

California Proposition 65:
Listed. (Doxycycline Hyclate) contains a chemical known to the State of California to cause birth defects or other reproductive harm. Other Information

Revision Date: 08/31/2015
Revision Number: 0
Disclaimer: This document is generated to distribute health, safety and environmental data. It is not a specification sheet and none of the displayed data should be construed
as a specification. Information on this SDS sheet was obtained from sources which we believe are reliable, and we believe that the information is complete and accurate.
However, the information is provided without any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn are from
sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of the product are beyond our control and may also be
beyond our knowledge. It is the user's responsibility to determine the suitability of any material for a specific purpose and to adopt such safety precautions as may be necessary.
If the product is used as a component in another product, this SDS information may not be applicable. For these reasons, we do not assume any responsibility and expressly
disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of this product.

Source: http://www.akorn.com/documents/catalog/msds/61748-111-14.pdf