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

Onessip Diphenhydramine Hcl 12.5 Mg / 5 Ml Oral Solution For Children
SPL v1
SPL
SPL Set ID 407b7cbb-7ebd-7b7e-e063-6394a90af501
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

Identifiers & Packaging

Pill Appearance
Color: white
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 is taking 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, 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 is taking 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, 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: 2026-02-15T12:08:37.624259 · Updated: 2026-03-14T23:12:56.390264