CODEINE PHOSPHATE + ACETAMINOPHEN

Warnings in taking this drug include:

• Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
• The extended use of this product is not recommended because Codeine is habit-forming and can be abuse.
• Acetaminophen and codeine phosphate tablets contain sodium metabisulfite, that causes allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
• In the presence of head injury or other intracranial lesions, the respiratory depressant effect of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure.

You should check with your doctor immediately if any of these side effects occur when taking acetaminophen / codeine:

More common side effects:

• Difficult or Troubled Breathing
• Irregular, Fast or Slow, or Shallow Breathing
• Pale or Blue Lips, Fingernails, or Skin
• Shortness of Breath
• Drowsiness
• Lightheadedness
• Sleepiness

If any of the symptoms persist or worsen, call your doctor. Also, tell your healthcare provider if you experience any other symptoms while using this drug.

Precautions

Some medical conditions may interact with Acetaminophen/Codeine. Before using this medication, tell your doctor or pharmacist if any of the following apply to you:

• If you are pregnant, planning to become pregnant, or are breast-feeding.
• If you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement.
• If you have allergies to medicines, foods, or other substances.
• If you are allergic to other narcotic medicines (eg, Hydrocodone, Morphine, Oxycodone)
• If you have severe drowsiness, or you have or recently had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or an infection of the brain or nervous system.
• If you have the following medical condition:
  • History Of Heart Problems (eg, Corpulmonale, Slow or Irregular Heartbeat)
  • Low Blood Pressure, Stomach or Bowel Problems (eg, Blockage, Inflammation, Paralysis)
  • Inflammation of the Pancreas (Pancreatitis)
  • Gallbladder Problems
  • Liver Problems (eg, Hepatitis)
  • Kidney Problems, Seizures, Thyroid Problems, Adrenal Gland Problems (eg, Addison Disease), Curvature of the Spine (Scoliosis), Prostate Problems (eg, an Enlarged Prostate), or Trouble Urinating
  • Asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
• If you have recently had surgery (eg, stomach or bowel surgery) or are scheduled to have surgery.
• If you are in very poor health, are very overweight, are dehydrated or have low blood volume, or have stomach pain or constipation.
• If you have a history of drug or alcohol abuse or dependence, mood or mental problems, or suicidal thoughts or actions; or are going through withdrawal from alcohol or other substances.

Interactions

Tell your health care provider if you are taking any other medicines because some medicines may interact with acetaminophen/codeine.

• Isoniazid, Other narcotic pain medicines (eg, Morphine), Perampanel, or Sleep Medicines (eg, Zolpidem)

-They may increase the risk of acetaminophen/codeine’s side effects.

• Buprenorphine, Naltrexone, or Quinidine

-They may decrease acetaminophen/codeine’s effectiveness.

• Anticoagulants (eg, Warfarin) or Sodium Oxybate (GHB)

–The risk of their side effects may be increased by acetaminophen/codeine.

• Medicines that may harm the liver (eg, Methotrexate, Ketoconazole, certain medicines for HIV infection)

–The risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver.

It is important to inform your doctor about the drugs (prescription/nonprescription) that you are taking. This may interact with Acetaminophen/ Codeine and give adverse side effects or it may lessen how the drug works.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call emergency hotline.

Symptoms of overdose:

• Abdominal or Stomach Pain
• Bloody or Cloudy Urine
• Chills
• Constricted, Pinpoint, or Small Pupils (Black Part of the Eye)
• Convulsions
• Dark Urine
• Headache
• Increased Sweating
• Light-Colored Stools
• Loss of Appetite
• Loss of Consciousness
• Nausea
• Sudden Decrease in Amount of Urine
• Unpleasant Breath Odor
• Vomiting
• Vomiting of Blood
• Yellow Eyes or Skin