Hyosyne (Page 2 of 2)

OVERDOSAGE

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation.

Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

DOSAGE AND ADMINISTRATION

HYOSYNE ORAL DROPS
(Hyoscyamine Sulfate Oral Solution)

Dosage may be adjusted according to the conditions and severity of symptoms. Measuredosage very carefully.
Adults and pediatric patients 12 years of age and older: 1 to 2 mL every four hours or as needed. Do not exceed 12 mL in 24 hours.
Pediatric patients 2 to under 12 years of age: 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours.Pediatric patients under 2 years of age: The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed.

Body Weight Usual Dose Do Not Exceed
In 24 Hours
3.4 kg (7.5 lb.) 4 drops 24 drops
5 kg (11 lb.) 5 drops 30 drops
7 kg (15 lb.) 6 drops 36 drops
10 kg (22 lb.) 8 drops 48 drops

Package of Hyoscyamine Sulfate Oral Drops is accompanied with a dropper having markings of 3, 4, 5 DROPS, and 0.25 mL. The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate (mg) for each marking are as follows:

Approximate Equivalent Amount
Marking on Dropper Hyoscyamine Sulfate Oral Drops Solution (mL) Hyoscyamine Sulfate (mg)
3 DROPS 0.08 mL 0.01 mg
4 DROPS 0.11 mL 0.01375 mg
5 DROPS 0.14 mL 0.0175 mg
0.25 mL 0.25 mL 0.03125 mg

HYOSYNE ELIXIR
(Hyoscyamine Sulfate Elixir)
Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully.
Adults and pediatric patients 12 years of age and older: 1 to 2 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours.Pediatric patients 2 to under 12 years of age: Please see the following dosage guide is based on body weight. The doses may be repeated every four hours or as needed. Do not exceed 6teaspoonfuls in 24 hours.

Body Weight Usual Dose
10 kg (22 lb.) 1/4 teaspoon (1.25 mL)
20 kg (44 lb.) 1/2 teaspoonful (2.5 mL)
40 kg (88 lb.) 3/4 teaspoonful (3.75 mL)
50 kg (110 lb.) 1 teaspoonful (5 mL)

HOW SUPPLIED

HYOSYNE ORAL DROPS (Hyoscyamine Sulfate 0.125 mg per mL) is orange colored, flavored, and contains 5% alcohol. It is supplied in a 15 mL bottle with a calibrated dropper
HYOSYNE ELIXIR (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, flavored, and contains 20% alcohol. It is supplied in a pint (473 mL) bottle.

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

Rx only.

Manufactured by:
Silarx Pharmaceuticals, Inc.Carmel, NY 10512

Distributed by

Atlantic Biologicals

Miami, Fl 33179

17856-0514-5

image description
(click image for full-size original)
HYOSYNE hyoscyamine sulfate elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0514(NDC:54838-511)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate 0.125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
anhydrous citric acid
FD&C RED NO. 40
FD&C YELLOW NO. 6
glycerin
sodium benzoate
sodium citrate
sorbitol
sucrose
water
Product Characteristics
Color Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0514-5 5 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/1997
Labeler — ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
Name Address ID/FEI Operations
ATLANTIC BIOLOGICALS CORP. 047437707 repack (17856-0514), relabel (17856-0514)

Revised: 06/2021 ATLANTIC BIOLOGICALS CORP.

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