BENADRYL- diphenhydramine hydrochloride tablet, film coated 
Mechanical Servants, LLC

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.

----------

Benadryl ®

Drug Facts

Active ingredient (in each tablet)

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 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

adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division
Fort Washington, PA 19034 USA

Repackaged and distributed by Convenience Valet ®, Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Pouch Package

Children's
Miracle Network

Hospitals ®

minimum annual
$250,000
Donation

See details on back.

Benadryl®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

ULTRATABS ®*
*small tablet size

2 Pouches of 2 Tablets each

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Pouch Package

PRINCIPAL DISPLAY PANEL-25mg Tablet Pouch Package 6ct

Benadryl ®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

ULTRATABS ®*
*small tablet size

3 POUCHES OF 2 TABLETS EACH

Benadryl 6 ct

PRINCIPAL DISPLAY PANEL-25mg Tablet Pouch 25 Box

Benadryl ®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

ULTRATABS ®*
*small tablet size


25 POUCHES OF 2 TABLETS EACH

Benadryl 25ct

PRINCIPAL DISPLAY PANEL-25mg Tablet Pouch 30 Box

Benadryl ®

ALLERGY

Diphenhydramine HCl 25 mg | Antihistamine

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

ULTRATABS ®*
*small tablet size


30 POUCHES OF 2 TABLETS EACH

Benadryl 30 ct

BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6931
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code B;WL;25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6931-63 in 1 BLISTER PACK02/06/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/06/2017
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7963
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code B;WL;25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-7963-225 in 1 BOX07/10/2020
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:29485-7963-330 in 1 BOX10/19/2015
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/19/2015
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-1007
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code B;WL;25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-1007-42 in 1 PACKAGE09/01/2008
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2008
Labeler - Mechanical Servants, LLC (005530951)
Establishment
NameAddressID/FEIBusiness Operations
Mechanical Servants, LLC005530951relabel(29485-1007, 29485-6931, 29485-7963) , repack(29485-1007, 29485-6931, 29485-7963)
Establishment
NameAddressID/FEIBusiness Operations
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divison878046358manufacture(29485-1007, 29485-6931, 29485-7963) , analysis(29485-1007, 29485-6931, 29485-7963) , label(29485-1007, 29485-6931, 29485-7963) , pack(29485-1007, 29485-6931, 29485-7963)

Revised: 12/2021
Document Id: d204d436-4e24-0229-e053-2a95a90ac688
Set id: 53de0882-12ad-4c5c-bdb8-85d40d1da5e6
Version: 5
Effective Time: 20211214
 
Mechanical Servants, LLC