NIGHTTIME SLEEP-AID - diphenhydramine hydrochloride tablet 
Geri-Care Pharmaceutical Corp

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 caplet)

Diphenhydramine Hydrochloride 25mg

Purpose

Nighttime Sleep-aid

Uses

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:57896-785
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Color white Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 93XF;57344
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57896-785-72 72 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 01/01/2004
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2013
Document Id: 970090a3-20c7-4884-86a3-32698763c799
Set id: 0fce381f-28ef-4591-a569-c5d599a3b95f
Version: 1
Effective Time: 20131219
 
Geri-Care Pharmaceutical Corp