Oxycodone and Acetaminophen (Page 8 of 8)

MEDICATION GUIDE

Oxycodone and Acetaminophen Tablets, USP CII

ok″se-ko´dōn and ass-eet-ah-MEE-noe-fen

Oxycodone and acetaminophen tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and 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 and acetaminophen tablets:

  • Get emergency help right away if you take too much oxycodone and acetaminophen tablets (overdose). When you first start taking oxycodone and acetaminophen 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.Taking oxycodone and Acetaminophen 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 and Acetaminophen Tablets. They could die from taking it. Selling or giving away Oxycodone and Acetaminophen Tablets are against the law.
  • Store Oxycodone and Acetaminophen 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 and acetaminophen tablets if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.
  • Known hypersensitivity to oxycodone, acetaminophen, or any ingredient in Oxycodone and Acetaminophen Tablets

Before taking oxycodone and acetaminophen 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, or mental health problems.

Tell your healthcare provider if you are:

  • Pregnant or planning to become pregnant. Prolonged use of oxycodone and acetaminophen tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. Oxycodone and acetaminophen passes into breast milk and may harm your baby.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.

When taking oxycodone and acetaminophen tablets:

  • Dispose of expired, unwanted, or unused Oxycodone and Acetaminophen Tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of Oxycodone and Acetaminophen Tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash.
  • Do not change your dose. Take oxycodone and acetaminophen tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 6 hours as needed for pain. 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 and acetaminophen tablets regularly, do not stop taking oxycodone and acetaminophen tablets without talking to your healthcare provider.
  • After you stop taking oxycodone and acetaminophen tablets, dispose of unused tablets by flushing them down the toilet.

While taking oxycodone and acetaminophen tablets DO NOT:

  • Drive or operate heavy machinery, until you know how oxycodone and acetaminophen tablets affects you. Oxycodone and acetaminophen 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 and acetaminophen tablets may cause you to overdose and die.

The possible side effects of oxycodone and acetaminophen tablets:

  • 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 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 and acetaminophen tablets. Call your doctor for medical advice about side effects. You may also request medical information or to report suspected adverse reactions, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088.For more information go to dailymed.nlm.nih.gov

What are the ingredients in Oxycodone and Acetaminophen Tablets?

Active Ingredients: Oxycodone Hydrochloride and acetaminophen

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Revised: 04/2019

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg/325 mg (100 Tablet Bottle)

NDC 13107-043-01
Oxycodone and Acetaminophen
Tablets, USP CII
2.5 mg/325 mg
Multiple Strengths: Do not dispense unless
strength is stated.
Rx only 100 Tablets
AUROBINDO

2.5 mg
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg/325 mg (100 Tablet Bottle)

NDC 13107-044-01
Oxycodone and Acetaminophen
Tablets, USP CII
5 mg/325 mg
Multiple Strengths: Do not dispense unless
strength is stated.
Rx only 100 Tablets
AUROBINDO

5 mg
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 7.5 mg/325 mg (100 Tablet Bottle)

NDC 13107-045-01
Oxycodone and Acetaminophen
Tablets, USP CII
7.5 mg/325 mg
Multiple Strengths: Do not dispense unless
strength is stated.
Rx only 100 Tablets
AUROBINDO

7.5 mg
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg/325 mg (100 Tablet Bottle)

NDC 13107-046-01
Oxycodone and Acetaminophen
Tablets, USP CII
10 mg/325 mg
Multiple Strengths: Do not dispense unless
strength is stated.
Rx only 100 Tablets
AUROBINDO

10 mg
(click image for full-size original)

OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-043
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 2.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (off white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code U14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-043-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-043-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-043-05 500 TABLET in 1 BOTTLE None
4 NDC:13107-043-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201972 07/15/2013
OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-044
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (off white) Score 2 pieces
Shape CAPSULE Size 14mm
Flavor Imprint Code U15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-044-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-044-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-044-05 500 TABLET in 1 BOTTLE None
4 NDC:13107-044-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201972 07/15/2013
OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-045
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 7.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (off white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code U16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-045-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-045-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-045-05 500 TABLET in 1 BOTTLE None
4 NDC:13107-045-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201972 07/15/2013
OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-046
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 10 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (off white) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code U17
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-046-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-046-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-046-05 500 TABLET in 1 BOTTLE None
4 NDC:13107-046-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201972 07/15/2013
Labeler — Aurolife Pharma LLC (829084461)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 829084461 MANUFACTURE (13107-043), MANUFACTURE (13107-044), MANUFACTURE (13107-045), MANUFACTURE (13107-046)

Revised: 05/2019 Aurolife Pharma LLC

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