VALUMEDS NIGHTTIME SLEEP-AID

VALUMEDS NIGHTTIME SLEEP-AID

Drug Labeling and Warnings

Drug Details

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NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
SPIRIT PHARMACEUTICALS 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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VALUMEDS NIGHTTIME SLEEP-AID

Drug Facts

Active ingredient
(in each softgel)

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid

Uses

  • for 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

Ask a doctor before use if you have

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

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 right away. 1(800)222-1222

Directions

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

Inactive ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 96 ct BOTTLE LABEL

VALUMEDS™

Compare to the active ingredient

in UNISOM®*

NIGHTTIME

SLEEP-AID

DIPHENHYDRAMINE HCl 50 mg

NIGHTTIME SLEEP-AID

  • Fall Asleep Fast
  • Sleep Soundly
  • Wake Refreshed

Safe/Non-Habit Forming
96 SOFTGELS

LIQUID FILLED
ONE SOFTGEL PER DOSE

image description

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68210-2020
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 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code 206
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68210-2020-096 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/16/2018
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PRIVATE LIMITED677385498manufacture(68210-2020)

Revised: 12/2019
 
SPIRIT PHARMACEUTICALS LLC


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