DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule, liquid filled 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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 capsule)

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
  • do not use with NyQuil

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.

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 bedtime if needed or as directed by a doctor

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 25 mg

Quantity : 20000 Capsules
NDC. No : 53345-007-01

IMPORTANT: 

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

PRINCIPAL DISPLAY PANEL - Shipping Label
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
Coloryellow (clear) Scoreno score
ShapeCAPSULE (OBLONG) Size15mm
FlavorImprint Code PC4
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-007-011 in 1 BOX
120000 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-007), ANALYSIS(53345-007)

Revised: 04/2013
Document Id: 514dbf06-b00b-460d-900e-31d1fd31af54
Set id: 9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6
Version: 1
Effective Time: 20130410
 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.