Medication Guide

Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Aspirin (as’ pir in) Tablets CII

Hydrocodone Bitartrate and Aspirin 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 Aspirin Tablets:

• Get emergency help right away or call 911 if you take too much Hydrocodone Bitartrate and Aspirin Tablets (overdose). When you first start taking Hydrocodone Bitartrate and Aspirin 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 Aspirin 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 Aspirin Tablets. They could die from taking it. Selling or giving away Hydrocodone Bitartrate and Aspirin Tablets is against the law.
  
• Store Hydrocodone Bitartrate and Aspirin Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
  
• Increases risk of bleeding and ulcers.

Do not take Hydrocodone Bitartrate and Aspirin Tablets if you have:

• severe asthma, asthma in combination with runny nose and nasal polyps, trouble breathing, or other lung problems.
  
• a bowel blockage or have narrowing of the stomach or intestines.
  
• known hypersensitivity to hydrocodone or aspirin, or any ingredient in Hydrocodone Bitartrate and Aspirin Tablets.
  
• known allergy to nonsteroidal anti-inflammatory drug products (NSAIDs)
  
• a rare disorder in which your blood doesn’t clot normally (hemophilia)

Do not give Hydrocodone Bitartrate and Aspirin Tablets to a child or teenager with a viral illness. Reye’s syndrome, a life-threatening condition, can happen when aspirin (an ingredient in Hydrocodone Bitartrate and Aspirin Tablets) is used in children and teenagers who have certain viral illnesses.

Before taking Hydrocodone Bitartrate and Aspirin 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.
  
• stomach ulcers, or stomach or intestinal bleeding with use of acetylsalicylic acid (ASA) or NSAIDs

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take Hydrocodone Bitartrate and Aspirin Tablets, do not take more of Hydrocodone Bitartrate and Aspirin Tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Hydrocodone Bitartrate and Aspirin Tablets.
  
• pregnant or planning to become pregnant. Use of Hydrocodone Bitartrate and Aspirin Tablets for extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Taking NSAID-containing products like Hydrocodone Bitartrate and Aspirin Tablets at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
  
• breastfeeding. Hydrocodone bitartrate and aspirin passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
  
• develop any type of rash or fever. Contact your healthcare provider as soon as possible and stop taking Hydrocodone Bitartrate and Aspirin Tablets.

• 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 Aspirin Tablets with certain other medicines can cause serious side effects that could lead to death. Taking with corticosteroids or anticoagulants increases risk of ulcers and stomach/intestinal bleeding.

When taking Hydrocodone Bitartrate and Aspirin Tablets:

• Do not change your dose. Take Hydrocodone Bitartrate and Aspirin Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  
• For acute (short-term) pain, you may only need to take Hydrocodone Bitartrate and Aspirin Tablets for a few days. You may have some Hydrocodone Bitartrate and Aspirin Tablets left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused Hydrocodone Bitartrate and Aspirin Tablets.
  
• 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 Aspirin Tablets regularly, do not stop taking Hydrocodone Bitartrate and Aspirin Tablets without talking to your healthcare provider.
  
• Dispose of expired, unwanted, or unused Hydrocodone Bitartrate and Aspirin 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 Aspirin Tablets DO NOT:

• Drive or operate heavy machinery, until you know how Hydrocodone Bitartrate and Aspirin Tablets affects you. Hydrocodone Bitartrate and Aspirin 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 Aspirin Tablets may cause you to overdose and die.

The possible side effects of Hydrocodone Bitartrate and Aspirin Tablets:

• Bleeding, constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, rash, or fever. 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.

Get emergency medical help or call 911 right away if you have:

These are not all the possible side effects of Hydrocodone Bitartrate and Aspirin Tablets. Call your healthcare provider 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:
LGM Pharma Solutions, LLC
Irvine, CA 92614

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

7182-PD

Issued: 01/2024