VALUMEDS NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet 
SPIRIT PHARMACEUTICALS LLC

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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 - 36 COUNT BOTTLE CARTON

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

36 CAPLETS

image description

VALUMEDS NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0203
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0203-31 in 1 CARTON04/10/2018
136 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01004/10/2018
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 12/2023
Document Id: 0bf0c21c-acc4-3164-e063-6294a90abe45
Set id: 9319b6fd-6fe4-4f6a-91a3-31570f25aed9
Version: 5
Effective Time: 20231207
 
SPIRIT PHARMACEUTICALS LLC