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VALUMEDS NIGHTTIME SLEEP AID

Medically reviewed by Drugs.com. Last updated on Mar 13, 2020.

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: SPIRIT PHARMACEUTICALS LLC
NDC Code: 68210-0203

VALUMEDS NIGHTTIME SLEEP AID CAPLETS

Drug Facts

Active ingredients (in each caplet)

Diphenhydramine HCl 25mg

Purpose

nighttime sleep-aid

Uses

for the 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
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists 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.

Overdose warning

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 and over take 2 caplets at bedtime if needed, or as directed by a doctor
 children under 12 years   do not use

Other information

each caplet contains: calcium 23.52 mg

store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-333-9792

Distributed By: Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

VALUMEDS™

Compare to the active ingredient

in TYLENOL® SIMPLY SLEEP®*

NIGHTTIME

SLEEP AID

DIPHENHYDRAMINE HCl 25 mg

NON-HABIT FORMING

DOES NOT CONTAIN PAIN RELIEVER

VALUMEDS NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0203
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
LECITHIN, SOYBEAN 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeS5
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0203-31 BOTTLE in 1 CARTON
136 TABLET in 1 BOTTLE
2NDC:68210-0203-1100 TABLET in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/10/2018
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
NameAddressID/FEIOperations
ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(68210-0203)

Document Id: a0c2b09a-bb62-e716-e053-2a95a90ab0a3
Set id: 9319b6fd-6fe4-4f6a-91a3-31570f25aed9
Version: 2
Effective Time: 20200313
 
SPIRIT PHARMACEUTICALS LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer