SLEEP AID- diphenhydramine hcl tablet 
Kareway Product, Inc.

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

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not use

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

avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

take 2 tablets at bedtime if needed or as directed by your doctor.

Other information

Inactive ingredients

FDC blue #1, microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch, dicalcium phosphate, stearic acid, silcon dioxide, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol

Package label

Enter section text hereimage of Sleep-aid carton

SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0160
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETHANETHIOL (UNII: M439R54A1D)  
Product Characteristics
ColorblueScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code RM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0160-22 in 1 BOX
112 in 1 BLISTER PACK
2NDC:67510-0160-02 in 1 BOX
210 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/18/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2013
Document Id: 5e9a6c00-38aa-4e50-aa1e-f67f20f15e8b
Set id: b7596293-d30e-4079-ba7c-b387e5eec129
Version: 3
Effective Time: 20130215
 
Kareway Product, Inc.