PHYSICIANSCARE ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet, film coated

PhysiciansCare Allergy by

Drug Labeling and Warnings

PhysiciansCare Allergy by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet)

Diphenhydramine Hydochloride 25 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

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

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

DOSAGE & ADMINISTRATION

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.

INFORMATION FOR PATIENTS

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

INACTIVE INGREDIENT

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.

QUESTIONS

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Acme United Corporation (001180207)

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

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