Lortab 5/500mg

What is Lortab 5 and how is it used?

Lortab 5 is a prescription medicine used to treat the symptoms of Moderate to Severe Pain. Lortab 5 may be used alone or with other medications.

Lortab 5 belongs to a class of drugs called Analgesics, Opioid Combos.

It is not known if Lortab 5 is safe and effective in children younger than 2 years of age.

What are the possible side effects of Lortab 5?

Lortab 5 may cause serious side effects including:

• slow breathing with long pauses,
• blue colored lips,
• hard to wake up,
• skin redness,
• rash that spreads and causes blistering and peeling,
• noisy breathing,
• sighing,
• shallow breathing,
• lightheadedness,
• nausea,
• upper stomach pain,
• tiredness,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• vomiting,
• loss of appetite,
• dizziness,
• worsening tiredness,
• weakness,
• agitation,
• hallucinations,
• fever,
• sweating,
• shivering,
• fast heart rate,
• muscle stiffness,
• twitching,
• loss of coordination, and
• diarrhea

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Lortab 5 include:

• dizziness,
• drowsiness,
• feeling tired,
• nausea,
• vomiting,
• stomach pain,
• constipation, and
• headache

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Lortab 5. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.

INDICATIONS

Lortab 5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/500 mg) are indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage for adults should not exceed 8 tablets.

HOW SUPPLIED

Lortab ® 5/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/500 mg) contain hydrocodone bitartrate 5 mg and acetaminophen 500 mg. They are supplied as white with blue specks, capsule-shaped, bisected tablets, debossed “ucb” on one side and “902” on the other side, in containers of 100 tablets NDC 50474-902-01, 500 tablets NDC 50474-902-50, and in hospital unit-dose packages of 100 tablets [4 X 25] NDC 50474-902-60.

STORAGE: Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature]

Dispense in a tight, light-resistant container with a child-resistant closure.