SPL v2
SPL
SPL Set ID d8462e6f-a9fb-4701-97e2-d81a47f3e196
Route
ORAL
Published
Effective Date 2024-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Fd&c Red No. 40 Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol Sucrose Water

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-19
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
Section 42229-5

Drug Facts

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Directions
  • take every 4-6 hours
  • Do not use more than 6 dose in 24 hours
adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 years ask a doctor

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin.
Other Information
  • store at room temperature 15º - 30ºC (59º - 86ºF)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 8 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients

cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Questions Or Comments?

1-844-474-7464

Principal Display Panel

Rising Health, LLC

NDC 57237-305-12

Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

4 fl oz (118 mL)

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children.
Active Ingredient in Each 5 Ml

Diphenhydramine HCl, 12.5 mg

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet

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

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Purpose

Antihistamine

Directions
  • take every 4-6 hours
  • Do not use more than 6 dose in 24 hours
adults and children 12 years of age and over 2 to 4 teaspoonfuls (25 to 50 mg)
children 6 to under 12 years of age 1 to 2 teaspoonfuls (12.5 to 25 mg)
children under 6 years ask a doctor

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin.
Other Information (Other information)
  • store at room temperature 15º - 30ºC (59º - 86ºF)
  • protect from freezing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 8 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients (Inactive ingredients)

cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

Questions Or Comments? (Questions or comments?)

1-844-474-7464

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Rising Health, LLC

NDC 57237-305-12

Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

4 fl oz (118 mL)

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children.
Active Ingredient in Each 5 Ml (Active ingredient in each 5 mL)

Diphenhydramine HCl, 12.5 mg

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)
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis.
  • a sodium-restricted diet

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.137947 · Updated: 2026-03-14T23:04:15.032207