FDA.reportPublic FDA data

Diphenhydramine hydrochloride

Manufacturer
Plastikon Healthcare, LLC
Effective date
2018-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:31:25

Label at a glance#

ProductDiphenhydramine hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Diphenhydramine HCl 12.5 mg/ 5 mL Cups

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tray for 5 mL and 10 mL CupsTray for 5 mL and 10 mL CupsDiphen HCL 12.5 mg - 5ML Approved LidDiphen 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

DOSAGE & ADMINISTRATION SECTION

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 mLCup Lid Graphic 5 mL

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

WARNINGS SECTION

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 INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Antihistamine

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

OTC - ACTIVE INGREDIENT SECTION

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 SAFETY INFORMATION

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

INSTRUCTIONS FOR USE SECTION

Diphen 5mL IFU Rev 2 final ProofDiphen 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tray for 5 mL and 10 mLl CupsTray for 5 mL and 10 mLl CupsDiphen HCl 10 mL lidDiphen 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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Antihistamine

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

OTC - ACTIVE INGREDIENT SECTION

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

OTHER SAFETY 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

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

INSTRUCTIONS FOR USE SECTION

Diphen 10 mL IFU Rev2 final ProofDiphen 10 mL IFU Rev2 final Proofroduct 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62320-010-052021-01-29C16284748780-1ba0f9c33-4320-a910-e053-dadaa90a0b85Diphenhydramine 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
62320-010-102021-01-29C16284748780-1ba0f9c33-4320-a910-e053-dadaa90a0b85Diphenhydramine 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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62320-01062320-010-05, 62320-010-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
POLOXAMER 407TUF2IVW3M2IACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7c76c171-fcfd-4594-e053-2991aa0ac05215862092-5cdc-3897-e054-00144ff88e882018-12-07WarningsExact identifier
spl id: 7c76c171-fcfd-4594-e053-2991aa0ac052
spl set id: 15862092-5cdc-3897-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.