SLEEP AID- sleep aid capsule, liquid filled 
Better Living Brands LLC

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410 - Sleep Aid

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.

If pregnant or 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: Take1 softgel (50mg) at bedtime if needed, or as directed by a doctor

Other information

Inactive ingredients

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

Questions/Comments

Call1-888-952-0050 (Mon-Fri 9AM-5PM EST)

Principal Display Panel

Sleep Aid

Sleep Aid

SLEEP AID 
sleep aid capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-052
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 PC5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-052-9696 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2023
2NDC:21130-052-321 in 1 CARTON11/08/2023
232 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01011/08/2023
Labeler - Better Living Brands LLC (009137209)

Revised: 7/2023
Document Id: 55b982d5-3d49-421a-9d28-eb2bd8a10b7e
Set id: 2b730fa5-47f9-468d-86ed-0d49d9cd8dc4
Version: 2
Effective Time: 20230706
 
Better Living Brands LLC