Diphenhydramine Oral Solution

Diphenhydramine Oral Solution
SPL v1
SPL
SPL Set ID 48ede5ab-207b-cf0c-e063-6394a90a419f
Route
ORAL
Published
Effective Date 2026-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Water Sucralose Anhydrous Citric Acid Propylene Glycol Methylparaben Propylparaben Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01
Description

Diphenhydramine KCI 12.5mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine KCI 12.5mg

Uses
  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

  • runny nose
  • sneezing
Section 51945-4

Warnings

Do not use

with any other drug containing diphenhydramine, including one used on the skin.

to make a child sleepy

Directions

  • Take every 4 hours, as needed, or as directed by a doctor
  • Do not take more than 6 doses in 24 hours
  • adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful
  • Children under 12 years: consult a doctor

Do Not Use

  • with any other drug containing diphenhydramine, including one used on the skin.
  • to make a child sleepy
Other Information

  • TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
  • store at room temperature between 15-30°C (59-86°F)
  • do not freeze
  • protect from light
  • Pharmacist: For dispensing, use a light-resistent container with a child-resistant cap
Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question Or Comments?

305-592-9216 or [email protected]

When Using This Product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving motor vehicle or operating machinery
  • avoid alcoholic drinks
If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • a breathing problem such as chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • glaucoma
Active Ingredient (in Each 5 Ml Teaspoonful)

Diphenhydramine KCI 12.5mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses
  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

  • runny nose
  • sneezing
Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

Do not use

with any other drug containing diphenhydramine, including one used on the skin.

to make a child sleepy

Directions

  • Take every 4 hours, as needed, or as directed by a doctor
  • Do not take more than 6 doses in 24 hours
  • adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful
  • Children under 12 years: consult a doctor

Do Not Use (Do not use)

  • with any other drug containing diphenhydramine, including one used on the skin.
  • to make a child sleepy
Other Information (Other information)

  • TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
  • store at room temperature between 15-30°C (59-86°F)
  • do not freeze
  • protect from light
  • Pharmacist: For dispensing, use a light-resistent container with a child-resistant cap
Inactive Ingredient

artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question Or Comments? (Question or Comments?)

305-592-9216 or [email protected]

When Using This Product (When using this product)

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving motor vehicle or operating machinery
  • avoid alcoholic drinks
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • glaucoma
Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL-teaspoonful))

Diphenhydramine KCI 12.5mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:21.204147 · Updated: 2026-03-14T23:12:34.529887