Onessip Diphenhydramine Hcl 12.5 Mg / 5 Ml Oral Solution For Children (cherry)

Onessip Diphenhydramine Hcl 12.5 Mg / 5 Ml Oral Solution For Children (cherry)
SPL v1
SPL
SPL Set ID 4157e680-37ac-eb4c-e063-6394a90a2a99
Route
ORAL
Published
Effective Date 2025-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Edetate Disodium Anhydrous Citric Acid Sucralose Sodium Saccharin Water Sodium Benzoate Sorbitol Solution Sodium Citrate Xanthan Gum Glycerin Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-06
Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Warnings and Precautions

Warnings

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
Section 43683-2

Addition of picture

Section 50565-1

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)

Section 50567-7

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet
Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51945-4

Directions
  • mL = milliliter
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 doses (6 sachets) in 24 hours
  • follow the instruction given on this carton for your easy use

Age (years) Dose (mL)
Children under 2 Years do not use
Children 2 to 5 Years do not use unless directed by doctor
Children 6 to 11 Years 1 Sachet (5 mL) to 2 Sachets (10 mL)

Other Information
  • store between 20-25°C (68-77°F)
  • Do not use if carton or sachet is torn, broken or punctured.
Inactive Ingredients

Sorbitol, sodium benzoate, sucralose, citric acid anhydrous, sodium citrate, flavor, FD&C Red No. 40, xanthan gum, glycerin, sodium saccharin, sodium EDTA, water.

Question Or Comments?

call 1-516-675-8915

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
Warnings and Precautions (34071-1)

Warnings

Section 43683-2 (43683-2)

Addition of picture

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet
Section 50570-1 (50570-1)

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 51945-4 (51945-4)

Purpose

Antihistamine

Directions
  • mL = milliliter
  • take every 4 to 6 hours or as directed by a doctor
  • do not take more than 6 doses (6 sachets) in 24 hours
  • follow the instruction given on this carton for your easy use

Age (years) Dose (mL)
Children under 2 Years do not use
Children 2 to 5 Years do not use unless directed by doctor
Children 6 to 11 Years 1 Sachet (5 mL) to 2 Sachets (10 mL)

Other Information
  • store between 20-25°C (68-77°F)
  • Do not use if carton or sachet is torn, broken or punctured.
Inactive Ingredients

Sorbitol, sodium benzoate, sucralose, citric acid anhydrous, sodium citrate, flavor, FD&C Red No. 40, xanthan gum, glycerin, sodium saccharin, sodium EDTA, water.

Question Or Comments? (Question or comments?)

call 1-516-675-8915

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:43.932455 · Updated: 2026-03-14T23:13:06.603726