PHYSICIANSCARE ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet, film coated 
Acme United Corporation

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.

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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

temporarily relieves these symptoms due to the common cold

Warnings

Do Not Use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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

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

BOX16790056-revC.jpg

Carton 167

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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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (Pink) Scoreno score
ShapeOVAL (Oval) Size11mm
FlavorImprint Code 048;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-0056-0150 in 1 CARTON11/01/2017
11 in 1 PACKET; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (Pink) Scoreno score
ShapeOVAL (Oval) Size11mm
FlavorImprint Code 061;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-0036-0150 in 1 CARTON11/01/2017
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2017
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-0056, 0924-0036) , repack(0924-0056, 0924-0036)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(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
 
Acme United Corporation