diphenhydramine hcl capsules, usp

diphenhydramine hcl capsules, usp
SPL v5
SPL
SPL Set ID f184b2aa-91a4-44f9-b688-d4e318181984
Route
oral
Published
Effective Date 2013-05-20
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: AP;21 Shape: capsule Color: pink Size: 14 mm Score: 1
Marketing Status
otc monograph drug active Since 2000-02-15
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Purpose

Antihistamine

Dosage and Administration

Directions

  • adults and children 12 years and over:take 1 to 2 capsules every 4 to 6 hours; not more than 6 doses in 24 hours
  • children under 12 years:ask a doctor

Other information

  • store at 15-30°C(59-86°F)
  • protect from moisture
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

Section 42229-5

Drug Facts

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

When Using This Product
  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Questions Or Comments? 

call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED

*Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy.

Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA

RI1010

Principle Display Panel

Richmond Pharmaceuticals, Inc.

*Compare to active ingredient in BENADRYL® Allergy

Diphenhydramine HCI Capsules, USP

25 mg

50 mg

ANTIHISTAMINE

100 CAPSULES (10 x 10)

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
Package Label.principal Display Panel
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes
Purpose

Antihistamine

Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and over:take 1 to 2 capsules every 4 to 6 hours; not more than 6 doses in 24 hours
  • children under 12 years:ask a doctor

Other information

  • store at 15-30°C(59-86°F)
  • protect from moisture
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

Section 42229-5 (42229-5)

Drug Facts

Active Ingredient (Active ingredient)

(in each capsule)

Diphenhydramine HCl 25 mg

When Using This Product (When using this product)
  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Questions Or Comments?  (Questions or comments? )

call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF BLISTER PACK IS TORN OR DAMAGED

*Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the trademark BENADRYL® Allergy.

Distributed by: Richmond Pharmaceuticals Inc., Richmond, VA 23233 Made in USA

RI1010

Principle Display Panel

Richmond Pharmaceuticals, Inc.

*Compare to active ingredient in BENADRYL® Allergy

Diphenhydramine HCI Capsules, USP

25 mg

50 mg

ANTIHISTAMINE

100 CAPSULES (10 x 10)

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
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.888254 · Updated: 2026-03-14T23:06:27.679265