Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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SLEEP TABS FOR NIGHTTIME USE- diphenhydramine hcl tablets tablet 
Allegiant Health

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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Drug Facts

Active ingredient

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Uses

relief of occasional sleeplessness

Warnings

Do not use

  • with any other products containing diphenhydramine, including one used on skin
  • in children under 12 years of age

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

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • 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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and children 12 years and over

take 2 tablets at bedtime if needed or as directed by a doctor

Children under 12 years of age

do not use

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide 

Package/Label Principal Display Panel

Diphenhydramine HCl 25mg

Diphenhydramine HCl 25mg

SLEEP TABS  FOR NIGHTTIME USE
diphenhydramine hcl tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-247
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code AZ247
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-247-2424 in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product04/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33804/28/2015
Labeler - Allegiant Health (079501930)

Revised: 12/2018
 
Allegiant Health


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