Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as follows:
10 mg/325 mg
White to off-white, capsule shape with H10/325 on one side and R bisect P on the other side.
Bottles of 30 NDC 76420-215-30 (Repackaged from NDC 42858-203-01)
Bottles of 60 NDC 76420-215-60 (Repackaged from NDC 42858-203-01)
Bottles of 90 NDC 76420-215-90 (Repackaged from NDC 42858-203-01)
Bottles of 100 NDC 76420-215-01 (Relabeled from NDC 42858-203-01)
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly
PRECAUTIONS; Information for Patients/Caregivers]
Repackaged and Relabeled by:
Torrance, CA 90501
|This Medication Guide has been approved by the U.S. Food and Drug Administration. ||Issued: 03/2021 |
|Medication Guide |
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate)
and Acetaminophen (a seet” a min’ oh fen)
| Hydrocodone bitartrate 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 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 hydrocodone bitartrate and acetaminophen tablets: |
- Get emergency help or call 911 right away if you take too many hydrocodone bitartrate and acetaminophen tablets (overdose). When you first start taking hydrocodone bitartrate 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 hydrocodone bitartrate 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 hydrocodone bitartrate and acetaminophen tablets. They could die from taking them. Selling or giving away hydrocodone bitartrate and acetaminophen tablets is against the law.
- Store hydrocodone bitartrate 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 hydrocodone bitartrate 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 hydrocodone or acetaminophen, or any ingredient in hydrocodone and acetaminophen tablets.
| Before taking hydrocodone bitartrate and acetaminophen tablets, tell your healthcare provider if you have a history of: |
- head injury, seizures
- problems urinating
- abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
| Tell your healthcare provider if you are: |
- Pregnant or planning to become pregnant. Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- Breastfeeding. Hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.
| When taking hydrocodone bitartrate and acetaminophen tablets: |
- Do not change your dose. Take hydrocodone bitartrate 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 four to six 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 hydrocodone bitartrate and acetaminophen tablets regularly, do not stop taking hydrocodone bitartrate and acetaminophen tablets without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused hydrocodone bitartrate 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 hydrocodone bitartrate and acetaminophen tablets DO NOT: |
- Drive or operate heavy machinery, until you know how hydrocodone bitartrate and acetaminophen tablets affect you. Hydrocodone bitartrate 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 hydrocodone bitartrate and acetaminophen tablets may cause you to overdose and die.
| The possible side effects of hydrocodone bitartrate and acetaminophen tablets: |
Get emergency medical help or call 911 right away if you have:
- Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
- 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 hydrocodone bitartrate 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
Repackaged and Relabeled by:
Torrance, CA 90501
PRINCIPAL DISPLAY PANEL
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
hydrocodone bitartrate and acetaminophen tablet
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:76420-215(NDC:42858-203) |
|Route of Administration ||ORAL ||DEA Schedule ||CII
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|HYDROCODONE BITARTRATE (HYDROCODONE) ||HYDROCODONE BITARTRATE ||10 mg |
|ACETAMINOPHEN (ACETAMINOPHEN) ||ACETAMINOPHEN ||325 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| SILICON DIOXIDE || |
| MAGNESIUM STEARATE || |
| CROSPOVIDONE || |
| POVIDONE K30 || |
| STARCH, CORN || |
| STEARIC ACID || |
|Product Characteristics |
|Color ||white (white to off-white) ||Score ||2 pieces |
|Shape ||OVAL (capsule shaped — 6.35 mm X 13.97 mm) ||Size ||14mm |
|Flavor || ||Imprint Code ||R;P;H10;325 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:76420-215-30 ||30 TABLET in 1 BOTTLE ||None |
| 2 ||NDC:76420-215-60 ||60 TABLET in 1 BOTTLE ||None |
| 3 ||NDC:76420-215-90 ||90 TABLET in 1 BOTTLE ||None |
| 4 ||NDC:76420-215-01 ||100 TABLET in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA202991 ||04/12/2016 || |
|Labeler — Asclemed USA, Inc.
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|ASCLEMED USA INC. DBA ENOVACHEM || ||059888437 ||relabel (76420-215), repack (76420-215) |
Revised: 05/2022 Asclemed USA, Inc.