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Nighttime Sleepaid

Dosage form: capsule, gelatin coated
Ingredients: Diphenhydramine Hydrochloride 50mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0557

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.

Pure-Aid
NIGHTTIME SLEEP-AID

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

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
  • take only one dose per day (24 hours) - see Overdose warning
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
  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • Protect from light

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

NIGHTTIME SLEEPAID 
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0557
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride50 mg  in 2 
Inactive Ingredients
Ingredient NameStrength
FD&C Blue No. 1 
gelatin 
glycerin 
POLYETHYLENE GLYCOL 400 
water 
FD&C Red No. 40 
sorbitol 
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeSLAD
Contains    
Packaging
#Item CodePackage Description
1NDC:67510-0557-112 BLISTER PACK in 1 CARTON
12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
2NDC:67510-0557-224 BLISTER PACK in 1 CARTON
22 CAPSULE, GELATIN COATED in 1 BLISTER PACK
3NDC:67510-0557-336 BLISTER PACK in 1 CARTON
32 CAPSULE, GELATIN COATED 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/FEIOperations
DongKoo Pharm. Ind. Co., Ltd.688235474manufacture(67510-0557)

Revised: 10/2014
 
Kareway Product, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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