Your browser does not support JavaScript! NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP]
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RxNorm Names

NIGHTTIME SLEEP-AID (diphenhydramine hcl) tablet
[Geri-Care Pharmaceutical Corp]


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 caplet)

Diphenhydramine Hydrochloride 25mg

Purpose

Nighttime Sleep-aid

Uses

  • relieves occasional sleeplessness

Warnings

Do not use

• in children under 12 years

• with any other product containing diphenhydramine, including one used

on skin


Ask a doctor before use if you have

• a breathing problem such as emphysema, asthma, 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 produc
t

• avoid alcoholic beverages

• drowsiness will occur

• avoid driving a motor vehicle or operating machinery


Stop use and ask a doctor if
• sleeplessness persists continuously for more than two 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and over: take two caplets at bedtime if needed, or as directed by a doctor

• do not exceed recommended dose

Other information

  • each caplet contains: calcium 85mg
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)

Inactive ingredients

calcium phosphate, croscarmellose sodium, magnesium stearate,

microcrystalline cellulose, silica.

package label

NDC 57896-785-72

Health Star

the sensible choice for price and health


NightTime Sleep-Aid

with Diphenhydramine HCl


72 Caplets

25 mg each

Compare to active ingredient in Nytol

Night time sleep aid label

NIGHTTIME SLEEP-AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57896-785
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 93XF;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-785-7272 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/01/2004
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2013
 
Geri-Care Pharmaceutical Corp

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