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

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NIGHTTIME SLEEP AID-Diphenhydramine HCl 25 mg

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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
  • trouble urinating due to an enlarged prostate gland
  • heart disease

Ask your 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

Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium,  Stearic Acid, Colloidal Silicon Dioxide, Magnesium Stearate, Film Coat AMB Blue, Polyethylene Glycol, Polyvinyl Alcohol, Brilliant Blue Lake, Indico Carmel Lake, Titanium dioxide, Talc

Questions or comments?

Call 1-844-832-1138

9AM – 5PM Monday-Friday

Principal Display Panel

Diphenhydramine HCl 25 mg/Nighttime sleep-aid

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 ®.

label

NDC 71679-110-10

NIGHTTIME SLEEP AID 
diphenhydramine hcl 25 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-110
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71679-110-03300 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
2NDC:71679-110-06600 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
3NDC:71679-110-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01001/01/2022
Labeler - Health Pharma USA LLC (080804485)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(71679-110)

Revised: 10/2023
Document Id: 08da137b-bf5c-886c-e063-6294a90a1da3
Set id: d659f747-9790-8bd6-e053-2995a90ae793
Version: 5
Effective Time: 20231020
 
Health Pharma USA LLC