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NDC 70518-1259-00 Diphenhydramine HCl 25 mg 25 mg/1 Details

Diphenhydramine HCl 25 mg 25 mg/1

Diphenhydramine HCl 25 mg is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 70518-1259-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70518-1259
Product ID	70518-1259_e3b09f43-b866-b6ef-e053-2a95a90aca10
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Diphenhydramine HCl 25 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	REMEDYREPACK INC.
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-1259-00 (70518125900)

Pricing Information	N/A
NDC Package Code	70518-1259-0
Billing NDC	70518125900
Package	20 CAPSULE in 1 BOTTLE, PLASTIC (70518-1259-0)
Marketing Start Date	2018-06-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8baaf99-d535-426f-801d-058662a429c5 Details

Active ingredient (in each capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

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

runny nose
itchy nose or throat
sneezing
itchy, watery eyes

Warnings

Do not use

with any otherprodcut containing diphenhydramine, even one use on skin
to make a child sleepy

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Drug Facts continued of back of label

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take every 4-6 hours
do not take more than 6 doses 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 at room temperature
protect from moisture

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

SPL UNCLASSIFIED SECTION

Drug Facts

PRINCIPAL DISPLAY PANEL

DRUG: Diphenhydramine HCl 25 mg

GENERIC: Diphenhydramine HCl

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1259-0

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: AP;20

PACKAGING: 20 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

D&C RED NO. 28
METHYLPARABEN
SODIUM LAURYL SULFATE
GELATIN
POLYSORBATE 80
PROPYLPARABEN
BENZYL ALCOHOL
BUTYLPARABEN
FD&C BLUE NO. 1
FD&C RED NO. 40
LACTOSE
MAGNESIUM STEARATE

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 25 MG

diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-1259(NDC:69618-024)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 28 (UNII: 767IP0Y5NH)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GELATIN (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	pink (Half pink and half white)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;20
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-1259-0	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/14/2018

Labeler - REMEDYREPACK INC. (829572556)

Revised: 7/2022

Document Id: e3b09f43-b866-b6ef-e053-2a95a90aca10

Set id: a8baaf99-d535-426f-801d-058662a429c5

Version: 7

Effective Time: 20220713

Search by Drug Name or NDC

NDC 70518-1259-00 Diphenhydramine HCl 25 mg 25 mg/1 Details

Diphenhydramine HCl 25 mg 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70518-1259-00 (70518125900)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a8baaf99-d535-426f-801d-058662a429c5 Details

Active ingredient (in each capsule)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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