SLEEP AID- diphenhydramine hydrochloride tablet 
Navarro Discount Pharmacies,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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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

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59970-079
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape ROUND Size 9mm
Flavor Imprint Code BD
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59970-079-16 2 in 1 BOX
1 10 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 02/01/2013
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 2/2013
Document Id: 6511a44e-9951-42f4-8ef7-8539430a344c
Set id: f3c500b9-1fdd-4382-921d-b333d92d34e7
Version: 2
Effective Time: 20130208
 
Navarro Discount Pharmacies,LLC