NDC 0904-0049 Formula Em
Dextrose (glucose), Levulose (fructose), Phosphoric Acid Solution Oral

Product Information

Formula Em is a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Formula Em is dextrose (glucose), levulose (fructose), phosphoric acid. The product's dosage form is solution and is administered via oral form.

Product Code0904-0049
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Formula Em
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dextrose (glucose), Levulose (fructose), Phosphoric Acid
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Major Pharmaceuticals
Labeler Code0904
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-15-1994
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Formula Em?


Product Characteristics

Color(s)RED (C48326 - CLEAR)
Flavor(s)CHERRY (C73375)

Product Packages

NDC 0904-0049-20

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

Price per Unit: $0.01590 per ML

Product Details

What are Formula Em Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Formula Em Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 318146 - dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG in 5 mL Oral Solution
  • RxCUI: 318146 - fructose 374 MG/ML / glucose 374 MG/ML / phosphoric acid 4.3 MG/ML Oral Solution
  • RxCUI: 318146 - dextrose 1.87 GM / fructose 1.87 GM / phosphoric acid 21.5 MG per 5 ML Oral Solution

Formula Em Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Formula Em Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Phosphorated carbohydrate solution*

*Each 5mL contains:

  • •3.74g Total sugar [dextrose (glucose) 1.87g, levulose (fructose) 1.87g]
  • •21.5mg Phosphoric acid

Purpose



Upset stomach reliever


Uses



  • •for relief of upset stomach associated with nausea

Warnings



  • •this product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI)

Do Not Use If You Have



  • •allergic reactions to any of the ingredients in this product

Ask A Doctor Before Use If You Have



  • •diabetes

Stop Use And Ask A Doctor If



  • •symptoms persist, return or get worse

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • •for maximum effectiveness, never dilute or drink fluids of any kind immediately before or after taking this product
  • •adults and children 12 years of age and over: 15 mL to 30 mL
  • •children 2 to under 12: 5 mL to 10 mL
  • •repeat dose every 15 minutes or until distress subsides
  • •do not take more than 5 doses in 1 hour without consulting a doctor
  • •only use the dose cup provided

Other Information



  • •store at 20-25°C (68-77°F) away from heat and direct light; keep from freezing.
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



FD&C red no. 40 aluminum lake, flavor, glycerin, methylparaben, purified water


Questions Or Comments?



1-800-616-2471


Package/Label Principal Display Panel



Formula EM

Anti-Nausea Liquid

For children and adults

Relief for nausea due to upset stomach

Cherry Flavor

No Antihistamines, Aspirin, Alcohol, Caffeine

COMPARE TO the active ingredients of EMETROL®

4 FL. OZ. (118 mL)


* Please review the disclaimer below.