Diphenhydramine hydrochloride

Set ID
6f1caac9-abc4-4f37-8c42-8d3fc6360ba9
Manufacturer
Central Texas Community Health Centers
Effective date
2016-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:39

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

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

Other Label Information

Inactive ingredients

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

Questions or comments?

1-800-616-2471

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

CommUnityCare Federally Qualified Health Centers DIPHENHYDRAMINE 25mg/24 Caps Date: Name: Dr. USE AS DIRECTED. 123456 1/1/01 DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24 Batch: 123456 Lot: 123456 Exp: 1/1/01 MAJOR Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Products

NDC Codes

Ingredients

NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
BUTYLPARABEN3QPI1U3FV8IACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 806OZP39ZG8HIACT

Complete SPL Sections

Active ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CommUnityCare Federally Qualified Health Centers DIPHENHYDRAMINE 25mg/24 Caps Date: Name: Dr. USE AS DIRECTED. 123456 1/1/01 DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24 Batch: 123456 Lot: 123456 Exp: 1/1/01 MAJOR Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/6f1caac9-abc4-4f37-8c42-8d3fc6360ba9/6c18aa4b-c649-4da4-ac84-20dad41b3b81.xml
XML SHA-256
badfd0a7e37933117c3a05b8d9bcb621c35c5cd20241c0a066bbfd174b63a997
XML bytes
28368

Legacy File Index

FolderFileDate
otc6c18aa4b-c649-4da4-ac84-20dad41b3b81.xml2016-04-08
otcdiphenhydramine-01.jpg2016-04-08