ALLERGY RELIEF  - diphenhydramine hcl tablet 
We Care Distributor Inc

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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Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses


Warnings

Do not use


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

Ask a doctor before use if you have


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

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
  • be careful when driving a motor vehicle or operating a machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding

ask a health professional before use.

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)

Directions


Other Information


Inactive Ingredients

colloidal silicon dioxide, croscarmallose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, titanium dioxide, d and c red, lecithin, polyvinyl alcohol, polyethylene glycol, talc.

Questions or comments?

Call: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

NDC: 70005-001-25

We Care

For Good Health

ALLERGY RELIEF

COMPARE TO THE ACTIVE INGREDIENT IN

Benadryl

CAPSULES

TO OPEN PUSH IN TAB AND PULL OUT

Diphenhydramine HCL, 25 mg

Antihistamine

Relieves:

This product is not manufactured or distributed by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark of Benadryl Capsules.

25 Pouches of 2 Coated Caplets

image 25


ALLERGY RELIEF  
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-001
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code EL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-001-2525 in 1 BOX
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:70005-001-5050 in 1 BOX
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:70005-001-022 in 1 BOX
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2016
Labeler - We Care Distributor Inc (079832998)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceutical Ltd.915664486manufacture(70005-001)

Revised: 2/2016
Document Id: 44f9f277-7a42-4b14-850e-a88627a64126
Set id: 8975e347-ab18-4c6d-bc36-fb2b889130c3
Version: 2
Effective Time: 20160202
 
We Care Distributor Inc