Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE capsule
-
NDC Code(s):
62207-664-21,
62207-664-22,
62207-664-23,
62207-664-31, view more62207-664-32, 62207-664-33, 62207-664-35
- Packager: Granules India Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated August 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACETAMINOPHEN 500 mg & DIPHENHYDRAMINE HCl 25 mg
RAPID RELEASE GELCAPS
Each Rapid Release Gelcap Contains:
Acetaminophen USP 500 mg and Diphenhydramine Hydrochloride USP 25 mgBOX LABEL
Batch No.: XXX No. of Units 5 x 5000 Mfg. Dt.: MMM/YYYY Gross Wt.: 0.00 kg Exp. Dt.: MMM/YYYY Tare Wt:. 0.00 kg Mfg. Lic. No.: 37/RR/AP/2003/F/R Net Wt.: 0.00 kg NDC No. XXXXX-XXX-XX Box Number: 000 Storage: Store at 20 – 25C (68 – 77F); excursions permitted to 15 – 30 C (59 – 86F); Preserve in tightly closed containers. Caution For Repacking only. POUCH LABEL
Batch No.: XXX No. of Units 5000 Mfg. Dt.: MMM/YYYY Exp. Dt.: MMM/YYYY Mfg. Lic. No.: 37/RR/AP/2003/F/R NDC No. XXXXX-XXX-XX Storage: Store at 20 – 25C (68 – 77F); excursions permitted to 15 – 30 C (59 – 86F); Preserve in tightly closed containers. Caution For Repacking only. Gil/PL/041
Product Code: XXXXXXX
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
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
acetaminophen and diphenhydramine hydrochloride capsuleProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-664 Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) HYDROXYPROPYL CELLULOSE (1200000 WAMW) (UNII: U3JF91U133) FD&C RED NO. 40 (UNII: WZB9127XOA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN (UNII: 2G86QN327L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TRIACETIN (UNII: XHX3C3X673) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) SHELLAC (UNII: 46N107B71O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color blue (dark blue/light blue) Score no score Shape CAPSULE (banded two-part capsule) Size 20mm Flavor Imprint Code G;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-664-21 5000 in 1 BOX 01/14/2014 2 NDC:62207-664-22 25000 in 1 BOX 01/14/2014 3 NDC:62207-664-23 30000 in 1 BOX 01/14/2014 4 NDC:62207-664-31 5000 in 1 POUCH 01/14/2014 5 NDC:62207-664-32 10000 in 1 POUCH 01/14/2014 6 NDC:62207-664-33 25000 in 1 POUCH 01/14/2014 11/13/2019 7 NDC:62207-664-35 25000 in 1 BOX 11/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 01/14/2014 Labeler - Granules India Limited (915000087) Registrant - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 manufacture(62207-664) , analysis(62207-664)
