Diphenhydramine Hcl 2.5mg/ml Unit Dose Cups, 12.5mg/5 Ml, 25mg/10ml

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (2.5 mg)

Inactive Ingredients

Trisodium Citrate Dihydrate Water Sorbitol Sucralose Xanthan Gum Citric Acid Monohydrate Glycerin Propylene Glycol Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2021-09-16

Medication Information

Purpose

Antihistamine

How Supplied

• NDC 81033-003-05 (12.5mg) unit dose cup

• NDC 81033-003-10 (25 mg) unit dose cup

Description

Diphenhydramine HCl 12.5mg

Uses

For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

Directions

Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.

Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

Do Not Use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

• this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland

Other Information

• each 5 mL contains: 16mg of sodium

• store at 20°-25°C (68°-77°F)

• tamper evident: DO NOT use if foil on cup is missing or torn

• Alcohol Free, Dye Free, Sugar Free

• NDC 81033-003-05 (12.5mg) unit dose cup

• NDC 81033-003-10 (25 mg) unit dose cup

Inactive Ingredients

citric acid, glycerin, propylene glycol, water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum, mixed berry flavor, strawberry flavor

Questions Or Comments?

Call 1-833-537-4679

Principal Display Panel

[ Barcode]

NDC 81033-003-05

Diphenhydramine

HCl Oral Solution

Delivers 12.5mg / 5 mL

12.5mg / 5 mL

Store at 68° - 77° F

[ Lot # Exp Date]

PKG by Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

NDC 81033-003-10

Diphenhydramine

HCl Oral Solution

Delivers 25mg / 10 mL

12.5mg / 5 mL

Store at 68° - 77° F

[Lot #] PKG by

[Exp Date] Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

When Using This Product

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

• avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Keep Our of Reach of Children

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

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5mg

Ask A Doctor Before Use If Your Child Has

• a breathing problem such as chronic bronchitis

• glaucoma

• a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If the Child Is

• taking sedatives or tranquilizers

Structured Label Content

Uses (USES)

For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)

Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor.

Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

Do Not Use (Do not use)

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin

• this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland

How Supplied (HOW SUPPLIED)

• NDC 81033-003-05 (12.5mg) unit dose cup

• NDC 81033-003-10 (25 mg) unit dose cup

Other Information (OTHER INFORMATION)

• each 5 mL contains: 16mg of sodium

• store at 20°-25°C (68°-77°F)

• tamper evident: DO NOT use if foil on cup is missing or torn

• Alcohol Free, Dye Free, Sugar Free

• NDC 81033-003-05 (12.5mg) unit dose cup

• NDC 81033-003-10 (25 mg) unit dose cup

Inactive Ingredients (INACTIVE INGREDIENTS)

citric acid, glycerin, propylene glycol, water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum, mixed berry flavor, strawberry flavor

Questions Or Comments? (QUESTIONS or COMMENTS?)

Call 1-833-537-4679

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

[ Barcode]

NDC 81033-003-05

Diphenhydramine

HCl Oral Solution

Delivers 12.5mg / 5 mL

12.5mg / 5 mL

Store at 68° - 77° F

[ Lot # Exp Date]

PKG by Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

NDC 81033-003-10

Diphenhydramine

HCl Oral Solution

Delivers 25mg / 10 mL

12.5mg / 5 mL

Store at 68° - 77° F

[Lot #] PKG by

[Exp Date] Kesin Pharma

Phoenix, AZ

Sugar, Alcohol, Dye Free

For Institutional Use Only

[Barcode]

When Using This Product (When using this product)

• marked drowsiness may occur

• sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

• avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Keep Our of Reach of Children (Keep our of reach of children)

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

Active Ingredient (in Each 5 Ml) (ACTIVE INGREDIENT (in each 5 mL))

Diphenhydramine HCl 12.5mg

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

• a breathing problem such as chronic bronchitis

• glaucoma

• a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

• taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.", "PURPOSE": "Antihistamine", "DIRECTIONS": "Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.", "Do not use": "• to make a child sleepy • with any other product containing diphenhydramine, even one used on skin • this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland", "HOW SUPPLIED": "• NDC 81033-003-05 (12.5mg) unit dose cup • NDC 81033-003-10 (25 mg) unit dose cup", "OTHER INFORMATION": "• each 5 mL contains: 16mg of sodium • store at 20°-25°C (68°-77°F) • tamper evident: DO NOT use if foil on cup is missing or torn • Alcohol Free, Dye Free, Sugar Free • NDC 81033-003-05 (12.5mg) unit dose cup • NDC 81033-003-10 (25 mg) unit dose cup", "INACTIVE INGREDIENTS": "citric acid, glycerin, propylene glycol, water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum, mixed berry flavor, strawberry flavor", "QUESTIONS or COMMENTS?": "Call 1-833-537-4679", "PRINCIPAL DISPLAY PANEL": "[ Barcode ] NDC 81033-003-05 Diphenhydramine HCl Oral Solution Delivers 12.5mg / 5 mL 12.5mg / 5 mL Store at 68° - 77° F [ Lot # Exp Date ] PKG by Kesin Pharma Phoenix, AZ Sugar, Alcohol, Dye Free For Institutional Use Only [Barcode] [Barcode] NDC 81033-003-10 Diphenhydramine HCl Oral Solution Delivers 25mg / 10 mL 12.5mg / 5 mL Store at 68° - 77° F [Lot #] PKG by [Exp Date] Kesin Pharma Phoenix, AZ Sugar, Alcohol, Dye Free For Institutional Use Only [Barcode]", "When using this product": "• marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children • avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.", "Keep our of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "ACTIVE INGREDIENT (in each 5 mL)": "Diphenhydramine HCl 12.5mg", "Ask a doctor before use if your child has": "• a breathing problem such as chronic bronchitis • glaucoma • a sodium-restricted diet", "Ask a doctor or pharmacist before use if the child is": "• taking sedatives or tranquilizers"}

Diphenhydramine Hcl 2.5mg/ml Unit Dose Cups, 12.5mg/5 Ml, 25mg/10ml

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information