ALLERGY RELIEF- diphenhydramine hcl 25 mg tablet 
Pioneer Life Sciences, 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.

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Diphenhydramine HCl 25 mg

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
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

When using this product

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 (1-800-222-1222) right away.

Directions

Other information

each tablets contains:

calcium 15 mg
store between 20-25°C (68-77°F). Avoid high humidity

Inactive ingredients

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OPADRY II

Questions or comments?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

Distributed by:
Pioneer Life Sciences
40E Cotters Lane, Suite A
East Brunswick, NJ 08816

label

ALLERGY RELIEF 
diphenhydramine hcl 25 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-021
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-021-25250 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2018
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 10/2018
Document Id: 94aece8d-ff74-4f13-858a-89c3da81bcad
Set id: 7c1a38de-555f-46e6-91c5-2d14aa9ab5d1
Version: 1
Effective Time: 20181001
 
Pioneer Life Sciences, LLC