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NDC 00924-0036-01 PhysiciansCare Allergy 25 mg/1 Details

PhysiciansCare Allergy 25 mg/1

PhysiciansCare Allergy is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Acme United Corporation. 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: 00924-0036-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	00924-0036
Product ID	0924-0036_5e31b1ff-2920-7b8c-e053-2a91aa0aedbc
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	PhysiciansCare Allergy
Proprietary Name Suffix	Antihistamine
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	Acme United Corporation
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 00924-0036-01 (00924003601)

Pricing Information	N/A
NDC Package Code	0924-0036-01
Billing NDC	00924003601
Package	50 PACKET in 1 CARTON (0924-0036-01) / 1 TABLET, FILM COATED in 1 PACKET
Marketing Start Date	2017-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc Details

SPL UNCLASSIFIED SECTION

Active Ingredients (in each tablet)

Diphenhydramine Hydochloride 25 mg

SPL UNCLASSIFIED SECTION

Purpose

Antihistamine

SPL UNCLASSIFIED SECTION

Uses

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

runny nose
sneezing
itching nose or throat
itchy-watery eyes

temporarily relieves these symptoms due to the common cold

runny nose
sneezing

SPL UNCLASSIFIED SECTION

Warnings

Do Not Use

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

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
difficuly in urination due to enlargement of the prostate gland
glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

* marked drowsiness may occur and avoid alcoholic beverages

* alcohol, sedatives and tranquilizers may increase the drowsiness effect

* use caution when driving a motor vehicle or operating machinery

* excitability may occur, especially in children

If pregnant or breast feeding, ask a health professional

before use

SPL UNCLASSIFIED SECTION

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

SPL UNCLASSIFIED SECTION

Directions

Do not use more than directed

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

SPL UNCLASSIFIED SECTION

Other information

each caplet may contain: calium 25mg
store at room temperature 59°-86°F (15°-30°C)
protect from light
use by expiration date on packet
tamper-evident sealed packets
do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

*may contain.

SPL UNCLASSIFIED SECTION

Questions?

1-800-835-2263

PRINCIPAL DISPLAY PANEL

BOX16790056-revC.jpg

PRINCIPAL DISPLAY PANEL

Box18490036-revC.jpg

INGREDIENTS AND APPEARANCE

PHYSICIANSCARE ALLERGY ANTIHISTAMINE

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0056(NDC:47682-167)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	pink (Pink)	Score	no score
Shape	OVAL (Oval)	Size	11mm
Flavor		Imprint Code	048;D
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-0056-01	50 in 1 CARTON	11/01/2017
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/01/2017

PHYSICIANSCARE ALLERGY ANTIHISTAMINE

diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0036(NDC:47682-184)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	pink (Pink)	Score	no score
Shape	OVAL (Oval)	Size	11mm
Flavor		Imprint Code	061;T
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-0036-01	50 in 1 CARTON	11/01/2017
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/01/2017

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-0056, 0924-0036) , repack(0924-0056, 0924-0036)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-0056, 0924-0036) , repack(0924-0056, 0924-0036)

Revised: 11/2017

Document Id: 5e31b1ff-2920-7b8c-e053-2a91aa0aedbc

Set id: 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc

Version: 1

Effective Time: 20171117

Search by Drug Name or NDC

NDC 00924-0036-01 PhysiciansCare Allergy 25 mg/1 Details

PhysiciansCare Allergy 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00924-0036-01 (00924003601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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