SLEEP AID- diphenhydramine hcl capsule, liquid filled 
Allegiant Health

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410-Sleep Aid Diphenhydramine HCl 50mg

Active ingredient(s)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use(s)

for relief of occasional sleeplessness

Warnings

Do not use

for children under 12 years of age 

  • with any other products containing diphenhydramine, even one used on skin  

Ask a doctor before use if

  • 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 persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Pregnancy/Breastfeeding

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 (1-800-222-1222) right away.

Directions

Adults and children 12 years and over: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor

Other information

Storage

store at room temperature 15° to 30°C (59° to 86°F) and avoid excessive heat  

Inactive ingredients

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

Questions

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Sleep Aid

Sleep Aid


SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-410
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-410-0910 in 1 CARTON; Type 0: Not a Combination Product11/09/2020
2NDC:69168-410-03250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/09/2020
3NDC:69168-410-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01011/09/2020
Labeler - Allegiant Health (079501930)

Revised: 11/2020
Document Id: aeadde5e-c4dd-453e-9dc6-1dfe096b0280
Set id: ec57db48-0f3a-4b12-8633-b45a4366c269
Version: 6
Effective Time: 20201106
 
Allegiant Health