Hyoscyamine Sulfate (Page 2 of 2)

DOSAGE AND ADMINISTRATION SECTION

Dosage may be adjusted according to the conditions and severity of symptoms.

Hyoscyamine Sulfate Tablets, USP must be taken orally.

Adults and pediatric patients 12 years of age and older

1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

Pediatric patients 2 to under 12 years of age

½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

HOW SUPPLIED SECTION

Bottles of 100
NDC 76439-0308-10

Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

SPL UNCLASSIFIED SECTION

Call your doctor about side effects. You may report side effects by calling (813)283-1344.

Manufactured for:
Virtus Pharmaceuticals, LLC. Tampa, FL 33619
www.virtusRX.com

L633L-02-VIR
Rev. 10/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description
(click image for full-size original)

HYOSCYAMINE SULFATE
hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-297(NDC:76439-308)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-297-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2015
Labeler — Direct_Rx (079254320)
Registrant — Direct_Rx (079254320)
Establishment
Name Address ID/FEI Operations
Direct_Rx 079254320 repack (61919-297)

Revised: 09/2019 Direct_Rx

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