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
Purpose

Antihistamine

Description

Diphenhydramine KCI 12.5mg

Medication Information

Warnings

Do not use

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

to make a child sleepy

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
Purpose

Antihistamine

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

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
Description

Diphenhydramine KCI 12.5mg

Section 51945-4

Do Not Use

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

Warnings

Do not use

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

to make a child sleepy

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
Purpose

Antihistamine

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

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
Section 51945-4 (51945-4)

Do Not Use (Do not use)

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