Your browser does not support JavaScript! SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [NAVARRO DISCOUNT PHARMACIES,LLC]
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RxNorm Names

SLEEP AID (diphenhydramine hcl) tablet
[Navarro Discount Pharmacies,LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each tablet)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not use

  • in 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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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 beverages

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.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years and older:
take 2 tablets at bedtime if needed or as directed by your doctor.

Other information

  • each tablet contains:calcium 0.2mg
  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

FD&C blue no. 2, hydroxypropyl cellulose, hypromellose 2910, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, silicic acid anhydride, sodium starch glycolate, stearic acid, titanium dioxide

Package label

Vida Mia Sleep Aid Original Formulaimage of Sleep-aid carton

SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59970-079
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE 
MICROCRYSTALLINE WAX 
ANHYDROUS LACTOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SILICON DIOXIDE 
HYPROMELLOSE 2910 (50 MPA.S) 
POLYETHYLENE GLYCOL 6000 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code BD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59970-079-162 in 1 BOX
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33802/01/2013
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 2/2013
 
Navarro Discount Pharmacies,LLC

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