SPL v1
SPL
SPL Set ID 297f7ffd-ca78-439e-8377-b495c3aed8ab
Route
ORAL
Published
Effective Date 2025-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Butylparaben Starch, Corn D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Anhydrous Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;107 Shape: capsule Color: pink Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01
Description

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine hydrochloride 25 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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5

Distributed by

BI-MART

Eugene, OR 97402

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use this product in children under 6 years of age

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy.
Questions?

call toll-free 1-844-912-4012

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide.

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Principal Display Panel 24 Count

Principal Display Panel 100 Count

Active Ingredient (in Each Capsule)

Diphenhydramine hydrochloride 25 mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

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)

Distributed by

BI-MART

Eugene, OR 97402

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use this product in children under 6 years of age

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy.
Questions?

call toll-free 1-844-912-4012

Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide.

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
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Principal Display Panel 24 Count (Principal Display Panel-24 Count)

Principal Display Panel 100 Count (Principal Display Panel-100 Count)

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine hydrochloride 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlarged prostate gland
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: 2026-02-15T12:06:22.718041 · Updated: 2026-03-14T23:09:06.809873