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PhysiciansCare Allergy Antihistamine

Medically reviewed on November 17, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Acme United Corporation
NDC Code: 0924-0056

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

PhysiciansCare Allergy

Active Ingredients (in each tablet)

Diphenhydramine Hydochloride 25 mg

Purpose


Antihistamine

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

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 the reach of children.

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

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.

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 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?

1-800-835-2263

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PHYSICIANSCARE ALLERGY  ANTIHISTAMINE
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0056(NDC:47682-167)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CARNAUBA WAX 
POLYETHYLENE GLYCOL 2000 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)  
TITANIUM DIOXIDE 
MAGNESIUM STEARATE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
HYPROMELLOSE 2208 (100 MPA.S) 
ANHYDROUS LACTOSE 
POLYSORBATE 80 
D&C RED NO. 27 
Product Characteristics
Colorpink (Pink) Scoreno score
ShapeOVAL (Oval) Size11mm
FlavorImprint Code048;D
Contains    
Packaging
#Item CodePackage Description
1NDC:0924-0056-0150 PACKET in 1 CARTON
11 TABLET, FILM COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2017
PHYSICIANSCARE ALLERGY  ANTIHISTAMINE
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0036(NDC:47682-184)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CARNAUBA WAX 
POLYETHYLENE GLYCOL 2000 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)  
TITANIUM DIOXIDE 
MAGNESIUM STEARATE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
HYPROMELLOSE 2208 (100 MPA.S) 
ANHYDROUS LACTOSE 
POLYSORBATE 80 
D&C RED NO. 27 
Product Characteristics
Colorpink (Pink) Scoreno score
ShapeOVAL (Oval) Size11mm
FlavorImprint Code061;T
Contains    
Packaging
#Item CodePackage Description
1NDC:0924-0036-0150 PACKET in 1 CARTON
11 TABLET, FILM COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2017
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIOperations
Acme United Corporation045924339relabel(0924-0056, 0924-0036), repack(0924-0056, 0924-0036)
Establishment
NameAddressID/FEIOperations
Acme United Corporation080119599relabel(0924-0056, 0924-0036), repack(0924-0056, 0924-0036)

 
Acme United Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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