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NDC 00363-0100-65 ALLERGY RELIEF 25 mg/1 Details

ALLERGY RELIEF 25 mg/1

ALLERGY RELIEF is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS. 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: 00363-0100-65
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00363-0100
Product ID	0363-0100_d4429698-b1c4-0624-e053-2a95a90a9ecd
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	ALLERGY RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIPHENHYDRAMINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	WALGREENS
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	2024-12-31

Package

Package Images

NDC 00363-0100-65 (00363010065)

Pricing Information	N/A
NDC Package Code	0363-0100-65
Billing NDC	00363010065
Package	365 TABLET, FILM COATED in 1 BOTTLE (0363-0100-65)
Marketing Start Date	2021-12-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c0270298-e7c5-e500-e053-2995a90aed23 Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

SPL UNCLASSIFIED SECTION

Purpose

Antihistamine

SPL UNCLASSIFIED SECTION

Uses

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

runny nose
itchy, watery eyes
sneezing
Itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

runny nose
sneezing

SPL UNCLASSIFIED SECTION

Warnings

Ask a doctor before use if you have

glaucoma
trouble urinating due to enlarged prostrate gland
a breathing problem such as emphysema or chronic bronchitis

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

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

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

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. (1-800-222-1222)

SPL UNCLASSIFIED SECTION

Directions

Take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years of age and over: 1 to 2 caplets

children 6 to under 12 years of age: 1 caplet

children under 6 years of age: do not use

SPL UNCLASSIFIED SECTION

Other information

each caplet contains: calcium 25 mg
protect from light
Store between 20-25°C (68-77° F)
use by expiration date on package

SPL UNCLASSIFIED SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0100
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	T061
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0100-65	365 in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2021
2	NDC:0363-0100-61	600 in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/31/2021

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC.		037052099	manufacture(0363-0100)

Revised: 12/2021

Document Id: d4429698-b1c4-0624-e053-2a95a90a9ecd

Set id: c0270298-e7c5-e500-e053-2995a90aed23

Version: 2

Effective Time: 20211228

Search by Drug Name or NDC

NDC 00363-0100-65 ALLERGY RELIEF 25 mg/1 Details

ALLERGY RELIEF 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0100-65 (00363010065)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c0270298-e7c5-e500-e053-2995a90aed23 Details

DRUG FACTS

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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