DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet 
Precision Dose, Inc.

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Diphenhydramine Hydrochloride

25 mg Tablets

For Hospital Use Only

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine 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 older1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

Inactive ingredients

carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-397-9228

Gluten Free

How Supplied

They are supplied as follows:
NDC 68094-018-61
Unit Dose Packages of 100 Tablets (10×10) per Carton

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1499
Rev. 10/23

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label

Precision Dose™

NDC 68094-018-61
Unit Dose

diphenhydrAMINE HCl
25 mg Tablets
100 Tablets
(10x10)

Each tablet contains:
Diphenhydramine Hydrochloride  25 mg
Calcium  20 mg

Gluten Free

USUAL DOSE: SEE ENCLOSED INSERT.

Store at 20-25°C (68-77°F).
Avoid high humidity. Protect from light.

Keep out of reach of children.
Hospital Use Only.

LC1498
R0

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-018(NDC:0113-0479)
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)  
crospovidone (120 .MU.M) (UNII: 68401960MK)  
D&C Red No. 27 (UNII: 2LRS185U6K)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Titanium dioxide (UNII: 15FIX9V2JP)  
anhydrous dibasic calcium phosphate (UNII: L11K75P92J)  
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeOVALSize10mm
FlavorImprint Code L479;25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-018-6110 in 1 CARTON07/15/2019
1NDC:68094-018-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01207/15/2019
Labeler - Precision Dose, Inc. (035886746)
Establishment
NameAddressID/FEIBusiness Operations
Precision Dose, Inc.035886746REPACK(68094-018)

Revised: 2/2024
Document Id: dc97bf2c-43bb-419e-9ce6-ef1fee42475a
Set id: 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4
Version: 3
Effective Time: 20240223
 
Precision Dose, Inc.