RxNorm Names

Review RxNorm Normal Forms

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

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f3c500b9-1fdd-4382-921d-b333d92d34e7

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 Formula

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 (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	BD
Contains

Packaging
#	Item Code	Package Description
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: 02/2013

Document Id: 6511a44e-9951-42f4-8ef7-8539430a344c

Set id: f3c500b9-1fdd-4382-921d-b333d92d34e7

Version: 2

Effective Time: 20130208

Navarro Discount Pharmacies,LLC

Daily Med

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