Me-PB-Hyos Elixir

Name: Me-PB-Hyos Elixir

Me-PB-Hyos Elixir

Me-PB-Hyos Elixir
Rx only

Rev. 04/2014

Clinical pharmacology

This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/ antispasmodic action and mild sedation.

Pregnancy

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Me-PB-Hyos Elixir . It is not known whether Me-PB-Hyos Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Me-PB-Hyos Elixir should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Me-PB-Hyos Elixir is administered to a nursing woman.

Dosage and administration

The dosage of Me-PB-Hyos Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

Pediatric patients: may be dosed every 4 to 6 hours.

   Starting Dosage
 Body weight              q4h  q6h
 10 lb. (4.5 kg)        0.5 mL  0.75 mL
 20 lb. (9.1 kg)              1.0 mL  1.5 mL
 30 lb. (13.6 kg)        1.5 mL  2.0 mL
 50 lb. (22.7 kg)        1/2 tsp  3/4 tsp
 75 lb. (34 kg)              3/4 tsp  1 tsp
 100 lb. (45.4 kg)        1 tsp 1  1/2 tsp

Principal display panel

NDC 58657-420-16
Me-PB-Hyos
Elixir
grape flavored
1 PINT

ME-PB-HYOS 
phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58657-420
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg  in 5 mL
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.1037 mg  in 5 mL
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.0194 mg  in 5 mL
SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.0065 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GLYCERIN  
WATER  
SACCHARIN SODIUM  
SORBITOL  
SUCROSE  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:58657-420-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/01/2014
Labeler - Method Pharmaceuticals, LLC (060216698)
Revised: 05/2014   Method Pharmaceuticals, LLC

For the Consumer

Applies to atropine / hyoscyamine / phenobarbital / scopolamine: oral capsule, oral elixir, oral liquid, oral tablet, oral tablet extended release

Along with its needed effects, atropine / hyoscyamine / phenobarbital / scopolamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking atropine / hyoscyamine / phenobarbital / scopolamine:

Rare
  • Eye pain
  • skin rash or hives
  • sore throat and fever
  • unusual bleeding or bruising
  • yellow eyes or skin

Some side effects of atropine / hyoscyamine / phenobarbital / scopolamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • decreased sweating
  • dizziness
  • dry mouth, nose, throat, or skin
Less common or rare
  • Bloated feeling
  • blurred vision
  • decreased flow of breast milk
  • difficult urination
  • difficulty in swallowing
  • headache
  • increased sensitivity of eyes to sunlight
  • loss of memory
  • nausea or vomiting
  • unusual tiredness or weakness

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