DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule, liquid filled 
AiPing Pharmaceutical, 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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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 at room temperature 15-30°C.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Softgels, USP 50 mg

Quantity : 13000 Softgels
NDC. No : 11788-018-00

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

diphen label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code AP018
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11788-018-001 in 1 BOX01/31/2015
113000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/31/201512/31/2019
Labeler - AiPing Pharmaceutical, Inc. (079674526)
Registrant - AiPing Pharmaceutical, Inc. (079674526)
Establishment
NameAddressID/FEIBusiness Operations
Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-018)

Revised: 5/2021
Document Id: c3297d78-bc2f-08d3-e053-2995a90af1a8
Set id: 5e71f7d7-07d5-d104-e053-2a91aa0a8bf9
Version: 2
Effective Time: 20210525
 
AiPing Pharmaceutical, Inc.