Hyoscyamine Sulfate (Page 2 of 2)

ADVERSE REACTIONS

All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.

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.

In rats, the LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.

DOSAGE AND ADMINISTRATION

Hyoscyamine Sulfate Oral Drops.
(Hyoscyamine Sulfate Oral Solution, USP)
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 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

Use 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

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 6 teaspoonfuls 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)

Hyoscyamine Sulfate Tablets, 0.125 mg

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

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: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

HOW SUPPLIED

Hyoscyamine Sulfate Oral Drops (hyoscyamine sulfate oral solution, USP) (Hyoscyamine Sulfate 0.125 mg per mL) is orange colored, lemon flavored, and contains 5% ethyl alcohol. It is supplied in a 20 mL bottle (NDC 62135-513-52).


Hyoscyamine Sulfate Elixir, USP (Hyoscyamine Sulfate 0.125 mg per 5 mL) is orange colored, lemon flavored, and contains 20% ethyl alcohol. It is supplied in a pint (473 mL) bottle (NDC 62135-511-47).

Hyoscyamine Sulfate Tablets, USP , 0.125 mg are white to off white, round tablets debossed with “CE” on one side and “116” on the other.

Bottles of 120
NDC 62135-512-12

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 for:

Chartwell RX, LLC.

Congers, NY 10920

Rev. 11/2022 L70981

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyoscyamine Sulfate Elixir, USP (0.125 mg/ 5 mL) — NDC 62135-511-47- 473mL label

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Hyoscyamine Sulfate Oral Solution, USP (0.125 mg/ 1 mL) — NDC 62135-513-52- 20mL label

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Hyoscyamine Sulfate Tablets, USP — 0.125 mg- NDC 62135-512-12- 120s-Bottle-label

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HYOSCYAMINE SULFATE hyoscyamine sulfate elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-511
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
LEMON
GLYCERIN
WATER
SODIUM BENZOATE
SODIUM CITRATE
SORBITOL
SUCROSE
Product Characteristics
Color orange Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-511-47 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/20/2022
HYOSCYAMINE SULFATE hyoscyamine sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-513
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 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
FD&C YELLOW NO. 6
LEMON
GLYCERIN
WATER
SODIUM BENZOATE
SODIUM CITRATE
SORBITOL
SUCROSE
Product Characteristics
Color orange Score
Shape Size
Flavor LEMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-513-52 20 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2022
HYOSCYAMINE SULFATE hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-512
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
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE, UNSPECIFIED
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (to off white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code CE;116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-512-12 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/17/2022
Labeler — Chartwell RX, LLC (079394054)
Establishment
Name Address ID/FEI Operations
Chartwell Pharmaceuticals Congers, LLC 118673447 analysis (62135-512), label (62135-512), manufacture (62135-512), pack (62135-512)
Establishment
Name Address ID/FEI Operations
Chartwell Pharmaceticals Carmel, LLC 118673485 analysis (62135-511), label (62135-511), manufacture (62135-511), pack (62135-511), analysis (62135-513), label (62135-513), manufacture (62135-513), pack (62135-513)

Revised: 10/2023 Chartwell RX, LLC

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