Hte - 1113 - 2019-1010

Hte - 1113 - 2019-1010
SPL v3
SPL
SPL Set ID 832eb36c-21c6-46d7-b1f8-ab8b6f1e501e
Route
ORAL
Published
Effective Date 2019-10-10
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 2012-08-06
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.

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.

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

Principal Display Panel

Harris Teeter

Allergy Relief

Compare to the Active Ingredient in Benadryl(R) Allergy Kapseals(R)

Diphenhydramine HCl, 25 mg

ANTIHISTAMINE

Relieves

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Capsules

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
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.

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)

Harris Teeter

Allergy Relief

Compare to the Active Ingredient in Benadryl(R) Allergy Kapseals(R)

Diphenhydramine HCl, 25 mg

ANTIHISTAMINE

Relieves

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 Capsules

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)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:57.910207 · Updated: 2026-03-14T23:04:20.034852