BENADRYL- diphenhydramine hydrochloride tablet, film coated 
Proficient Rx LP

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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Benadryl®

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
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 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

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 times in 24 hours

adults and children 12 years and over

1 to 2 tablets

children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other information

each tablet contains: calcium 15 mg
store between 20-25°C (68-77°F). Protect from light.
do not use if carton is opened or if blister unit is broken

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)

PRINCIPAL DISPLAY PANEL

NDC 71205-521-06

Benadryl®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing
✓ Runny Nose
✓ Itchy, Watery Eyes
✓ Itchy Throat

ULTRATABS®*
*small tablet size

actual size

6 TABLETS

71205-521-06
BENADRYL 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-521(NDC:50580-226)
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 aluminum lake (UNII: ZK64F7XSTX)  
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)  
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:71205-521-063 in 1 BAG01/01/2021
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 - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-521) , RELABEL(71205-521)

Revised: 1/2021
Document Id: b1c849e5-8003-4fd3-811d-6a927523e353
Set id: b1c849e5-8003-4fd3-811d-6a927523e353
Version: 1
Effective Time: 20210101
 
Proficient Rx LP