SLEEP AID- sleep aid capsule, liquid filled 
Allegiant Health

----------

SoundBody 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

If pregnant or breast-feeding, 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

Inactive ingredients

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

Principal Display Panel

Sleep Aid label

Sleep Aid label

Sleep Aid

Sleep Aid


SLEEP AID 
sleep aid capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-917
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:69168-917-401 in 1 CARTON10/14/2021
132 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01001/01/2007
Labeler - Allegiant Health (079501930)

Revised: 10/2021
Document Id: 8d85cfb4-db0f-4905-849d-d6c9d955263a
Set id: 9a0b347e-5719-42f3-9050-df5165495e88
Version: 2
Effective Time: 20211014
 
Allegiant Health