COMPRESSO PAP 90 CPF

Compresso PAP 90CPF by

Drug Labeling and Warnings

Compresso PAP 90CPF by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPRESSO PAP 90 CPF- compresso pap 90 cpf powder 
COMPRESSO PAP 90CPF- compresso pap 90cpf powder 
Granules India Limited

----------

COMPRESSO PAP 90 CPF

(Directly compressible granules containing Acetaminophen USP / Paracetamol Ph.Eur. - 90%)

SPECIMEN LABEL

Batch No.: XXX Drum No.: XXX

Mfg. Dt.: XXX Tare Wt.: XXX

Exp. Dt.: XXX Net Wt.: XXX

Mfg. Lic. No.: XXX Gross Wt.: XXX

NDC No. 62207-702

Storage: Preserve in tight, light resistant containers, and store at room temperature. Protect from moisture and heat.

Caution  For Manufacturing, Processing, or Repacking only.

GIL / PL / 41

Manufactured in India by:
Granules India Limited
Plot No. 160/A, 161/E, Gagillapur Village
Qutbullapur Mandal, Ranga Reddy Dt – 500 043, AP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compressoCompresso PAP 90 CPF

COMPRESSO PAP 90 CPF 
compresso pap 90 cpf powder
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC: 62207-101
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN90 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62207-101-1240000000 mg in 1 DRUM08/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only08/16/2017
COMPRESSO PAP 90CPF 
compresso pap 90cpf powder
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC: 62207-702
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN90 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSPOVIDONE (UNII: 68401960MK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62207-702-0110000000 mg in 1 BAG10/24/2013
2NDC: 62207-702-0225000000 mg in 1 BAG10/24/2013
3NDC: 62207-702-0340000000 mg in 1 BAG10/24/2013
4NDC: 62207-702-0450000000 mg in 1 BAG10/24/2013
5NDC: 62207-702-1125000000 mg in 1 BAG10/24/2013
6NDC: 62207-702-1240000000 mg in 1 BAG10/24/2013
7NDC: 62207-702-1350000000 mg in 1 BAG10/24/2013
8NDC: 62207-702-1460000000 mg in 1 BAG10/24/2013
9NDC: 62207-702-16100000000 mg in 1 BAG10/24/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only04/11/2013
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918457644api manufacture(62207-702, 62207-101) , analysis(62207-702)

Revised: 2/2023
Document Id: f5a8e0bb-dda6-4740-e053-2a95a90a4f56
Set id: fd69ba00-5490-4a3c-8071-731bcaed443e
Version: 7
Effective Time: 20230227
 
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.