1113-bst-2021-1117

1113-bst-2021-1117
SPL v4
SPL
SPL Set ID b84f37bc-be37-4f2b-83ee-d7d134184490
Route
oral
Published
Effective Date 2021-11-17
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 completed Since 2017-04-28 Until 2028-04-30

Purpose

Antihistamine

Description

Drug Facts


Medication Information

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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not exceed 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age 12.5 mg
12.5 mg dosage strength is not available in this package. Do not attempt to break capsules.
to 25 mg (1 capsule)
children under 6 years of age ask a doctor
Other Information
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from moisture
  • 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

Description

Drug Facts

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY†

Best Choice®

Antihistamine

Allergy Relief

Actual Size

Diphenhydramine HCl

For Allergy Relief

Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat

24 CAPSULES

25 MG EACH

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.

Section 50568-5

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

Section 50570-1

Do not use 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.

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

Diphenhydramine HCl 25 mg

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

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
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not exceed 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules)
children 6 to under 12 years of age 12.5 mg
12.5 mg dosage strength is not available in this package. Do not attempt to break capsules.
to 25 mg (1 capsule)
children under 6 years of age ask a doctor
Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from moisture
  • 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY†

Best Choice®

Antihistamine

Allergy Relief

Actual Size

Diphenhydramine HCl

For Allergy Relief

Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat

24 CAPSULES

25 MG EACH

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.

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 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.

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)