NIGHTTIME SLEEP AID- diphenhydramine hcl 25 mg tablet, coated 
Health Pharma USA LLC

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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Sleep Aid - Diphenhydramine HCL, 25mg Tablets

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

provides 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
  • 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 emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • heart disease

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers or any other sleep-aid

When using this product

  • drowsiness will occur
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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 a 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other Information

Inactive Ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

Principal Display Panel

Compare to Tylenol® Simply Sleep active ingredients*

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.

Diphenhydramine HCl Tablets, 25 mg

label

NIGHTTIME SLEEP AID 
diphenhydramine hcl 25 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-084
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71679-084-001 in 1 BOX06/01/2017
170000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2017
Labeler - Health Pharma USA LLC (080804485)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(71679-084)

Revised: 11/2019
Document Id: 96dd5993-b1ac-2480-e053-2995a90a9a8b
Set id: 96dd4e5a-b7ff-12dc-e053-2a95a90a7b54
Version: 1
Effective Time: 20191108
 
Health Pharma USA LLC