TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

Saatavilla:

Zydus Lifesciences Limited

INN (Kansainvälinen yleisnimi):

ACETAMINOPHEN

Koostumus:

ACETAMINOPHEN 325 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Tramadol hydrochloride and acetaminophen tablets are contraindicated for: -   all children younger than 12 years of age [see Warnings and Precautions (5.4)] -   post-operative management in children younger than 18 years of age following tonsillectomy and/or aden

Tuoteyhteenveto:

Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg are white, capsule-shaped, beveled-edge, biconvex, film-coated tablets, debossed "334" on one side and plain on other side and are supplied as follows: NDC 65841-758-01 in bottle of 100 tablets NDC 65841-758-05 in bottle of 500 tablets NDC 65841-758-10 in bottle of 1000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

ACETAMINOPHEN TABLET, FILM COATED
Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 0ba70e83-9193-4b54-833f-01fe76575960
34391-3
Set id: 39945812-f776-4b13-8199-e846e37aa101
Version: 7
Effective Time: 20230927
Zydus Lifesciences Limited

Valmisteyhteenveto

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE
AND ACETAMINOPHEN TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, C-IV
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg
NDC 65841-758-01
100 Tablets
Rx only
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
tramadol hydrochloride and acetaminophen tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-758
ROUTE OF ADMINISTRATION
ORAL
DEA SCHEDULE
CIV
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
ACETAMINOPHEN
325 mg
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL -
UNII:39J1LGJ30J)
TRAMADOL
HYDROCHLORIDE
37.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
15mm
FLAVOR
IMPRINT CODE
334
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-758-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
10/15/2012
2
NDC:65841-758-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
10/15/2012
3
NDC:65841-758-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
10/15/2012
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA090460
10/15/2012
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(65841-758) , MANUFACTURE(65841