Hydrocodone and Homatropine Tablets

• It is used to relieve coughing.

For all patients taking this medicine (hydrocodone and homatropine tablets):

• If you have an allergy to hydrocodone, homatropine, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine (hydrocodone and homatropine tablets) within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.

Children:

• If your child is younger than 6 years of age. Do not give this medicine to a child younger than 6 years of age.

This is not a list of all drugs or health problems that interact with this medicine (hydrocodone and homatropine tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Seizures.
• Very bad belly pain.
• Very bad headache.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Feeling very sleepy.
• Very hard stools (constipation).
• Feeling very tired or weak.
• Trouble passing urine.
• Anxiety.
• Mood changes.
• This medicine may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP are indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

Central Nervous System:

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.

Gastrointestinal System:

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of Hydrocodone Bitartrate and Homatropine Methylbromide tablets may produce constipation.

Genitourinary System:

Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression:

Hydrocodone Bitartrate and Homatropine Methylbromide tablets may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Use of Hydrocodone Bitartrate and Homatropine Methylbromide tablets in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with Hydrocodone Bitartrate and Homatropine Methylbromide tablets in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression.

Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.

Dermatological:

Skin rash, pruritus.

Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP are available as white, round scored, biconvex tablet debossed with "N" on upper side of the score, "350" on the lower side of the score and plain on the other side containing 5 mg hydrocodone bitartrate and 1.5 mg homatropine methylbromide and is available in

Bottles of 30 NDC 43386-118-03

Bottles of 100 NDC 43386-118-24

Bottles of 500 NDC 43386-118-26

Store tablets at 20°–25°C (68°–77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure (as required).

Oral prescription where permitted by state law.

Manufactured by:

Novel Laboratories, Inc.

400 Campus drive

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals; Inc

Baltimore, MD 21202

PI1180000203

Rev. 03/2017