Oxycodone and Acetaminophen (Page 8 of 8)

HOW SUPPLIED

Oxycodone and Acetaminophen Tablets, USP are supplied as follows:

5 mg/325 mg

Blue, round tablet, debossed with “LANNETT” and “1669” on one side and bisect on the other side.

Bottles of 100 NDC 0527-1669-01
Bottles of 500 NDC 0527-1669-05

10 mg/325 mg

Yellow, capsule-shaped tablet, debossed with “LANNETT” on one side and “1671” on the other side.

Bottles of 100 NDC 0527-1671-01
Bottles of 500 NDC 0527-1671-05

Storage

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients].

Distributed by:
Lannett Company, Inc. Philadelphia, PA 19136

CIB71342D

Rev. 08/20

Medication Guide

Oxycodone (ox” i koe’ done) and Acetaminophen (a seet” a min’ oh fen) Tablets, CII
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 O xycodone and Acetaminophen Tablets:

  • Get emergency help or call 911 right away if you take too much Ox ycodone 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • 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 is 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, opioid overdose, 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 pass 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 and Acetaminophen Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking Oxycodone and Acetaminophen Tablets:

  • 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.

  • Dispose of expired, unwanted, or unused Oxycodone and Acetaminophen Tablets 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 and Acetaminophen Tablets DO NOT:

  • Drive or operate heavy machinery, until you know how Oxycodone and Acetaminophen Tablets affect 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 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 and Acetaminophen 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.

Distributed by: Lannett Company, Inc., Philadelphia, PA 19136 or call 1-844-834-0530

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

CIB71343C
Rev. 08/20

5 mg/325 mg

NDC 0527-1669 -01

Oxycodone CII
and
Acetaminophen
Tablets, USP

5 mg/325 mg

Multiple strengths:
Do not dispense unlessstrength is stated.

Rx Only

100 TABLETS

5 mg
(click image for full-size original)

5 mg

10 mg/325 mg

NDC 0527-1671 -01

Oxycodone CII
and
Acetaminophen
Tablets, USP

10 mg/325 mg

Multiple strengths:
Do not dispense unlessstrength is stated.

Rx Only

100 TABLETS

10 mg
(click image for full-size original)

10 mg

OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1669
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
FD&C BLUE NO. 1
ALUMINUM OXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LANNETT;1669
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1669-01 100 TABLET in 1 BOTTLE None
2 NDC:0527-1669-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207333 09/25/2017
OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1671
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
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
ALUMINUM OXIDE
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 15mm
Flavor Imprint Code LANNETT;1671
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1671-01 100 TABLET in 1 BOTTLE None
2 NDC:0527-1671-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207333 09/25/2017
Labeler — Lannett Company, Inc. (002277481)

Revised: 08/2020 Lannett Company, Inc.

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