NDC 0904-6840 Milk Of Magnesia

Magnesium Hydroxide

NDC Product Code 0904-6840

NDC 0904-6840-72

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Milk Of Magnesia with NDC 0904-6840 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Milk Of Magnesia is magnesium hydroxide. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug 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.

Milk Of Magnesia Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM HYDROXIDE 2400 mg/10mL

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.

Labeler Name: Major Pharmaceuticals
Labeler Code: 0904
FDA Application Number: part331 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 06-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Milk Of Magnesia Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Diphenhydramine Hcl 12.5 Mg/ 5 Ml Cups

NDC 0904-6740-70
Diphenhydramine HClOral Solution, USP12.5 mg/5 mLAntihistamine - Delivers 5 mLSee InsertFor Instituional Use OnlyMAJOR PHARMACEUTICALSLivonia, MI 64152Sugar Free - Dye Free - Alcohol Free

Diphenhydramine Hcl 12.5 Mg/5 Ml Major Pharmaceuticals - Ifu - Institutional Use Only

Directions• Use the following dosage guidelines when using this productAge (yr)Dose (mL)adults and children 12 years and overtake 10 mL every 4 to 6 hours; not more than 60 mL in 24 hourschildren 6 years to under 12 yearstake 5 mL every 4 to 6 hours; not more than 30 mL in 24 hourschildren under 6 yearsask a doctor

Diphenhydramine Hcl 12.5 Mg/5 Ml Major Pharmaceuticals - Ifu - For Institutional Use Only

WarningsDo not use in neonates or premature infants if pregnant or breast-feeding if hypersensitive to diphenhydramine HCl and other similar antihistamines with any other product containing diphenhydramine, even one used on skin to make a child sleepy___________________________________________________________________Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis a sodium restricted diet trouble urinating due to an enlarged prostate gland___________________________________________________________________Ask a doctor or pharmacist before use if taking tranquilizers or sedatives___________________________________________________________________When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children___________________________________________________________________

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

  • Other information each 5 mL contains: sodium 15 mg store at 20-25°C (68-77°F) protect from excessive moisture do not use if lid seal is open or damaged sugar free, dye free, alcohol free see bottom of cup for lot number and expiration date

Diphenydramine Hcl 12.5 Mg/ 5 Ml Major Pharmaceutical - Ifu - For Institutional Use Only

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)

Diphenhydramine Hcl 12.5 Mg/ 5 Ml Major Pharmaceuticals - Ifu - For Intitutional Use Only

Antihistamine

Diphenhydramine Hcl 12.5 Mg/ 5 Ml Major Pharmaceuticals - Ifu - For Institutional Use Only

Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..………………………………………Antihistamine

  • Product InsertDiphenhydramine HCl Oral Solution, USPNDC 0904-6740-7010 x 5 mL Unit Dose CupsActive ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..………………………………………AntihistamineUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitchy throatWarningsDo not usein neonates or premature infantsif pregnant or breast-feedingif hypersensitive to diphenhydramine HCl and other similar antihistamineswith any other product containing diphenhydramine, even one used on skinto make a child sleepyAsk a doctor before use if you haveglaucomaa breathing problem such as emphysema or chronic bronchitisa sodium restricted diettrouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use iftaking tranquilizers or sedativesWhen using this productmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenKeep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)Other informationeach 5 mL contains: sodium 15 mgstore at 20-25°C (68-77°F)protect from excessive moisturedo not use if lid seal is open or damagedsugar free, dye free, alcohol freesee bottom of cup for lot number and expiration dateInactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucraloseDirectionsUse the following dosage guidelines when using this productAge (yr) Dose (mL)adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hourschildren 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hourschildren under 6 years ask a doctorQuestions or comments?Call 1-800-616-2471Re-order No. 700900MAJOR® PHARMACEUTICALS17177 N Laurel Park Dr., Suite 233Livonia, MI 48152

Diphenhydramine Hcl 25 Mg / 10 Ml Cups

NDC 0904-6741-72
Diphenhydramine HClOral Solution, USP25 mg/10 mLAntihistamine - Delivers 10 mLSee InsertFor Instituional Use OnlyMAJOR PHARMACEUTICALSLivonia, MI 64152Sugar Free - Dye Free - Alcohol Free

Diphenhydramine Hcl 25 Mg/ 10 Ml Major Pharmaceuticals - For Instutional Use Only

DirectionsUse the following dosage guidelines when using this productAge (yr) Dose (mL)adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hourschildren 6 years to under 12 years ask a doctor

Diphenhydramine Hcl 10 Mg/ 10 Ml Major Pharmaceuticals - For Institutional Use Only

WarningsDo not use • in neonates or premature infants• if pregnant or breast-feeding• if hypersensitive to diphenhydramine HCl and other similar antihistamines• with any other product containing diphenhydramine, even one used on skin• to make a child sleepy___________________________________________________________________Ask a doctor before use if you have• glaucoma • a breathing problem such as emphysema or chronic bronchitis• a sodium restricted diet • trouble urinating due to an enlarged prostate gland___________________________________________________________________Ask a doctor or pharmacist before use if• taking tranquilizers or sedatives___________________________________________________________________When using this product• marked drowsiness may occur • avoid alcoholic drinks• alcohol, sedatives, and tranquilizers may increase drowsiness• be careful when driving a motor vehicle or operating machinery• excitability may occur, especially in children

Diphenhydramine Hcl 25 Mg/ 10 Ml Major Pharmaceuticals - For Institutional Use Only

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

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)

Antihistamine

Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..………………………………………Antihistamine

Diphenhydramine Hcl 10 Mg / 10 Ml Major Pharmaceuticals - For Institutional Use Only

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

Diphenhydramine Hcl 25 Mg/ 10 Ml Major Pharmaceuticals - Ifu - For Institutional Use Only

  • • each 10 mL contains: sodium 30 mgstore at 20-25°C (68-77°F)protect from excessive moisturedo not use if lid seal is open or damagedsugar free, dye free, alcohol freesee bottom of cup for lot number and expiration date

  • Roduct Insert
  • Diphenhydramine HCl Oral Solution, USPNDC 0904-6741-7210 x 10 mL Unit Dose CupsActive ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..………………………………………AntihistamineUses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitchy throatWarningsDo not usein neonates or premature infantsif pregnant or breast-feedingif hypersensitive to diphenhydramine HCl and other similar antihistamineswith any other product containing diphenhydramine, even one used on skinto make a child sleepyAsk a doctor before use if you haveglaucomaa breathing problem such as emphysema or chronic bronchitisa sodium restricted diettrouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use iftaking tranquilizers or sedativesWhen using this productmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenKeep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)DirectionsUse the following dosage guidelines when using this productAge (yr) Dose (mL)adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hourschildren 6 years to under 12 years ask a doctorOther informationeach 10 mL contains: sodium 30 mgstore at 20-25°C (68-77°F)protect from excessive moisturedo not use if lid seal is open or damagedsugar free, dye free, alcohol freesee bottom of cup for lot number and expiration dateInactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucraloseQuestions or comments?Call 1-800-616-2471Re-orderNo. 700901MAJOR® PHARMACEUTICALS17177 N Laurel Park Dr., Suite 233Livonia, MI 48152

* Please review the disclaimer below.