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Diphenhydramine HCl by AiPing Pharmaceutical, Inc.

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: AiPing Pharmaceutical, Inc.
NDC Code: 11788-018

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.

Nighttime Sleep Aid
Diphenhydramine HCl Softgels, USP 50 mg

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use
  • for relief of occasional sleeplessness

Warnings

Do not use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persist 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 overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other Information
  • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.

ATTENTION: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS MISSING OR BROKEN. CHILD- RESISTANT PACKAGING.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Questions or comments?

Call toll free 1-844-374-0016

PRINCIPAL DISPLAY PANEL

NDC: 11788-018-32

* Compare to UNISOM ® SLEEPGELS ® Active Ingredient

* This product is not manufactured by Chattem, Inc., distributor of Unisom ®

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R.China

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-018
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
POLYETHYLENE GLYCOL 400 
GELATIN 
GLYCERIN 
SORBITOL 
FD&C BLUE NO. 1 
WATER 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeAP018
Contains    
Packaging
#Item CodePackage Description
1NDC:11788-018-321 BOTTLE in 1 CARTON
132 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/31/2015
Labeler - AiPing Pharmaceutical, Inc. (079674526)
Registrant - AiPing Pharmaceutical, Inc. (079674526)
Establishment
NameAddressID/FEIOperations
Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-018)

 
AiPing Pharmaceutical, Inc.

← See all Diphenhydramine HCl brands

Medically reviewed on Oct 27, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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