Dicyclomine Hydrochloride (Page 4 of 4)
17 PATIENT COUNSELING INFORMATION
17.2 Use in Infants
Inform parents and caregivers not to administer dicyclomine hydrochloride tablets in infants less than 6 months of age [see Use in Specific Populations ( 8.4)].
17.3 Use in Nursing Mothers
Advise lactating women that dicyclomine hydrochloride tablets should not be used while breastfeeding their infants [see Use in Specific Populations ( 8.3, 8.4)].
17.4 Peripheral and Central Nervous System
In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride tablets use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride tablets may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride tablets [see Warnings and Precautions ( 5.3)].
Distributed By:
Advagen Pharma Ltd.,
666 Plainsboro Road,
Suite 605
Plainsboro, NJ 08536, USA.
Manufactured by:
Rubicon Research Private Limited
Ambernath, Dist: Thane, 421506 India.
Rev. 12/2022
PRINCIPAL DISPLAY PANEL
Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-30 — 30 Tablets Label
Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-01 — 100 Tablets Label
Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-05 — 500 Tablets Label
Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-00 — 1000 Tablets Label
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride tablet | |||||||||||||||||||||||||
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Labeler — Advagen Pharma Ltd., (051627256) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Rubicon Research Private Limited | 677604197 | manufacture (72888-119), analysis (72888-119), label (72888-119) |
Revised: 01/2023 Advagen Pharma Ltd.,
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