Oxycodone Hydrochloride (Page 10 of 10)

Medication Guide

Oxycodone (ox” i koe’ done) HCl Tablets USP, CII

Oxycodone HCl tablets are:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about oxycodone HCl tablets:

Get emergency help or call 911 right away if you take too much oxycodone HCl tablets (overdose). When you first start taking oxycodone HCl tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.

Taking oxycodone HCl tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your oxycodone HCl tablets. They could die from taking it. Selling or giving away oxycodone HCl is against the law.
Store oxycodone HCl tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take oxycodone HCl tablets if you have:

severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
allergy to oxycodone.

Before taking oxycodone HCl tablets, tell your healthcare provider if you have a history of:

head injury, seizures
liver, kidney, thyroid problems
problems urinating
pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

pregnant or planning to become pregnant. Prolonged use of oxycodone HCl tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Oxycodone HCl passes into breast milk and may harm your baby.
living in a household where there are small children or someone who has abused street or prescription drugs
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone HCl tablets with certain other medicines can cause serious side effects that could lead to death.

When taking oxycodone HCl tablets:

Do not change your dose. Take oxycodone HCl tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Take your prescribed dose every 4 to 6 hours. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
Call your healthcare provider if the dose you are taking does not control your pain.
If you have been taking oxycodone HCl tablets regularly, do not stop taking oxycodone HCl tablets without talking to your healthcare provider.
Dispose of expired, unwanted, or unused oxycodone HCl by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking oxycodone HCl tablets DO NOT:

Drive or operate heavy machinery, until you know how oxycodone HCl tablets affects you. Oxycodone HCl tablets can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxycodone HCl tablets may cause you to overdose and die.

The possible side effects of oxycodone HCl tablets are:

constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of oxycodone HCl tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719

www.amneal.com or call 1-877-835-5472

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. 12-2021-03

Dispense with Medication Guide available at:

documents.amneal.com/mg/oxycodone-hcl-tab.pdf

Package/Label Display Panel

Oxycodone Hydrochloride Tablets, USP CII

5 mg

100 Tablets

Carton label
(click image for full-size original)

Package/Label Display Panel

Oxycodone Hydrochloride Tablets, USP CII

15 mg

100 Tablets

carton label
(click image for full-size original)
OXYCODONE HYDROCHLORIDE oxycodone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6966(NDC:65162-047)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code A;04
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6966-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6966-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203638 10/30/2012
OXYCODONE HYDROCHLORIDE oxycodone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7180(NDC:65162-049)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code A;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7180-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-7180-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203638 10/30/2012
Labeler — Major Pharmaceuticals (191427277)

Revised: 02/2022 Major Pharmaceuticals

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