1113-eln-2023-0517

1113-eln-2023-0517
SPL v5
SPL
SPL Set ID 08fda81a-bedd-4ff3-9c32-2066d2cea3f9
Route
ORAL
Published
Effective Date 2022-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Benzyl Alcohol Butylparaben D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: A;20 Shape: oval Color: pink Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-01
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 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 50568-5

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

Section 50570-1

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times 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

Other Information
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information
Inactive Ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments?

1-855-423-2630

Principal Display Panel

EQUALINE®

NDC 41163-613-03

compare to Benadryl® active ingredient*

allergy relief

diphenhydramine HCl 25mg

(antihistamine)

for relief of:

• sneezing

• runny nose

• itchy, watery eyes

• itchy throat

100 capsules

actual size

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 Capsule)

Diphenhydramine HCl 25 mg

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

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 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 50568-5 (50568-5)

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

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 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times 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

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions Or Comments? (Questions or comments?)

1-855-423-2630

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

EQUALINE®

NDC 41163-613-03

compare to Benadryl® active ingredient*

allergy relief

diphenhydramine HCl 25mg

(antihistamine)

for relief of:

• sneezing

• runny nose

• itchy, watery eyes

• itchy throat

100 capsules

actual size

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 Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 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 an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:51.559181 · Updated: 2026-03-14T23:04:09.079304