NIGHTTIME SLEEPAID- diphenhydramine hydrochloride capsule, gelatin coated 
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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Pure-Aid
NIGHTTIME SLEEP-AID

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep-aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

Directions

adults & children
12 yrs & over
One dose = TWO 25 mg Softgels (50 mg)
at bed time if needed or as directed by a doctor

Other information

Inactive ingredients

FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water

Exclusively distributed by:

Kareway Product, Inc.

2550 S. Dominguez Hills Dr.

Compton, CA  90220

Made in Korea

PRINCIPAL DISPLAY PANEL - 12 Capsule Carton

image of carton label

NIGHTTIME SLEEPAID 
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0557
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride50 mg  in 2 
Inactive Ingredients
Ingredient NameStrength
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
gelatin (UNII: 2G86QN327L)  
glycerin (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
water (UNII: 059QF0KO0R)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
sorbitol (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code SLAD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0557-112 in 1 CARTON
12 in 1 BLISTER PACK
2NDC:67510-0557-224 in 1 CARTON
22 in 1 BLISTER PACK
3NDC:67510-0557-336 in 1 CARTON
32 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33810/22/2014
Labeler - Kareway Product, Inc. (121840057)
Establishment
NameAddressID/FEIBusiness Operations
DongKoo Pharm. Ind. Co., Ltd.688235474manufacture(67510-0557)

Revised: 10/2014
Document Id: 4294707b-3c0b-4a75-96e0-61a18ba498d7
Set id: ff5d54bd-eb48-4383-9b75-6da0ecad1257
Version: 1
Effective Time: 20141022
 
Kareway Product, Inc.