VALUMEDS NIGHTTIME SLEEP AID CAPLETS

VALUMEDS NIGHTTIME SLEEP AID CAPLETS

Drug Labeling and Warnings

Drug Details

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VALUMEDS NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet 
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 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 finalpart33804/10/2018
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(68210-0203)

Revised: 4/2018
 
SPIRIT PHARMACEUTICALS LLC


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