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 72888-119-30 -- 30 Tablets Label
(click image for full-size original)

Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-01 — 100 Tablets Label

Dicyclomine Hydrochloride Tablets ,USP 20 mg -- NDC 72888-119-01 -- 100 Tablets Label
(click image for full-size original)

Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-05 — 500 Tablets Label

Dicyclomine Hydrochloride Tablets ,USP 20 mg -- NDC 72888-119-05 -- 500 Tablets Label
(click image for full-size original)

Dicyclomine Hydrochloride Tablets,USP 20 mg — NDC 72888-119-00 — 1000 Tablets Label

Dicyclomine Hydrochloride Tablets ,USP 20 mg -- NDC 72888-119-00 -- 1000 Tablets Label
(click image for full-size original)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-119
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (15 MPA.S)
STARCH, CORN
FD&C BLUE NO. 1 ALUMINUM LAKE
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color blue (light blue to blue) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code UpArrowhead;A2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72888-119-30 30 TABLET in 1 BOTTLE None
2 NDC:72888-119-01 100 TABLET in 1 BOTTLE None
3 NDC:72888-119-05 500 TABLET in 1 BOTTLE None
4 NDC:72888-119-00 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216736 12/14/2022
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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