DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid 
Plastikon Healthcare, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCl unit dose cups
Major Pharmaceuticals - For Institutional Use Only
5 mL cups 12.5 mg/ 5 mL
10 mL cups 25 mg/10 mL

Diphenhydramine HCl 12.5 mg/ 5 mL Cups

Tray for 5 mL and 10 mL CupsDiphen HCL 12.5 mg - 5ML Approved LidNDC 0904-6740-70

Diphenhydramine HCl

Oral Solution, USP

12.5 mg/5 mL

Antihistamine - Delivers 5 mL

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar 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 product

Age (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 hours

children 6 years to under 12 years

take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours

children under 6 years

ask a doctor

Cup Lid Graphic 5 mL

Diphenhydramine HCl 12.5 mg/5 mL
Major Pharmaceuticals - IFU - For Institutional Use Only

Warnings

Do 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 12.5 mg/5 mL
Major Pharmaceuticals - IFU - for Institutional Use Only

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

Diphenhydramine HCl 12.5 mg/5 mL
Major Pharmaceuticals - IFU - 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

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

Diphenhydramine HCl 12.5 mg/5 mL
Major Pharmaceuticals - IFU - For Institutional Use Only

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

Diphenhydramine HCl 12.5 mg/ 5 mL
Major Pharmaceuticals - IFU - For Institutional use Only

Diphen 5mL IFU Rev 2 final Proof

Product Insert

Diphenhydramine HCl Oral Solution, USP

NDC 0904-6740-70

10 x 5 mL Unit Dose Cups

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

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat

Warnings

Do 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

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)

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

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

Directions

Use the following dosage guidelines when using this product

Age (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 hours

children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours

children under 6 years ask a doctor

Questions or comments?

Call 1-800-616-2471

Re-order No. 700900

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Diphenhydramine HCl 25 mg / 10 mL Cups

Tray for 5 mL and 10 mLl CupsDiphen HCl 10 mL lidNDC 0904-6741-72

Diphenhydramine HCl

Oral Solution, USP

25 mg/10 mL

Antihistamine - Delivers 10 mL

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

Diphenhydramine HCl 25 mg/ 10 mL
Major Pharmaceuticals - for Instutional use Only

Directions

Use the following dosage guidelines when using this product

Age (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 hours

children 6 years to under 12 years ask a doctor

Diphenhydramine HCl 10 mg/ 10 mL
Major Pharmaceuticals - For Institutional Use Only

Warnings

Do 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

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 - 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 25 mg/ 10 mL
Major Pharmaceuticals - For Institutional Use Only

Antihistamine

Diphenhydramine HCl 25 mg/ 10 mL
Major Pharmaceuticals - For Institutional Use Only

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

Diphenhydramine HCl 25 mg/ 10 mL
Major Pharmaceuticals - IFU - For Institutional Use Only

• each 10 mL contains: sodium 30 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

Diphenhydramine HCl 25 mg/ 10 mL
Major Pharmaceuticals - IFU - For Institutional Use Only

Diphen 10 mL IFU Rev2 final Proof roduct Insert

Diphenhydramine HCl Oral Solution, USP

NDC 0904-6741-72

10 x 10 mL Unit Dose Cups

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

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat

Warnings

Do 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

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

Use the following dosage guidelines when using this product

Age (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 hours

children 6 years to under 12 years ask a doctor

Other information

  • each 10 mL contains: sodium 30 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

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

Questions or comments?

Call 1-800-616-2471

Re-order

No. 700901

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62320-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62320-010-0510 in 1 CASE12/04/2018
110 in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:62320-010-1010 in 1 CASE12/04/2018
210 in 1 TRAY
210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/04/2018
Labeler - Plastikon Healthcare, LLC (041717941)
Registrant - Plastikon Healthcare, LLC (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(62320-010)

Revised: 12/2018
Document Id: 7c76c171-fcfd-4594-e053-2991aa0ac052
Set id: 15862092-5cdc-3897-e054-00144ff88e88
Version: 3
Effective Time: 20181207
 
Plastikon Healthcare, LLC