ALLERGY RELIEF- diphenhydramine hydrochloride tablet 
Navarro Discount Pharmacies,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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Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCL 25mg

Purpose

Antihistamine

Uses

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking 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 accidental overdose get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age 25 mg (1 tablet)

children under 6 years of age

children under 4 years of age

ask a doctor

do not use

Other information

Inactive ingredients

FD&C red no. 40, hypromellose 2910, hydroxypropyl cellulose, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, silicic acid anhydride, stearic acid, titanium dioxide

Package label

Allergy Reliefimage of Allergy Relief cartonimage description

ALLERGY RELIEF 
diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59970-082
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color pink Score no score
Shape OVAL Size 11mm
Flavor Imprint Code ZN75
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59970-082-24 2 in 1 BOX
1 10 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/01/2013
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 2/2013
Document Id: 8cc0bed0-b8e4-4124-a592-74d3c104f675
Set id: ce711ae8-c2b8-423e-8241-1f322290ad9c
Version: 1
Effective Time: 20130213
 
Navarro Discount Pharmacies,LLC