s containing alcohol during treatment with tramadol hydrochloride and acetaminophen tablets may cause you to overdose and die.
The possible side effects of tramadol hydrochloride and acetaminophen tablets:
constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
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 tramadol hydrochloride 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
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
Indi
Issued: January 2017
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 37.5 MG/325 MG (30 TABLETS BOTTLE)
NDC 65862-922-30
Tramadol Hydrochloride and Acetaminophen Tablets USP CIV
37.5 mg/325 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
Rx only 30 Tablets
AUROBINDO
Figure-1
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 37.5 MG/325 MG - 100 (10X10) UNIT-DOSE TABLETS
NDC 65862-922-78
Tramadol Hydrochloride and Acetaminophen Tablets USP CIV
37.5 mg/325 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
Package Not Child-Resistant.
Rx only 100 (10 x 10) Unit-dose Tablets
AUROBINDO
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 Blister Carton (10 x 10 Unit-dose)
INGREDIENTS AND APPEARANCE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
tramadol hydrochloride and acetaminophen tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-922
Route of Administration ORAL DEA Schedule CIV
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE 37.5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3 |
