NIGHTTIME SLEEP-AID- diphenhydramine hcl tablet 
NORTHEAST PHARMA

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hpc 785

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 product

• avoid alcoholic beverages

• drowsiness will occur

• do not drive a motor vehicle or operate 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.

Questions or comments?

1-800-540-3765

package label

1

NIGHTTIME SLEEP-AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-785
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 93XF;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-785-9696 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01009/01/2021
Labeler - NORTHEAST PHARMA (081232935)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 10/2023
Document Id: 08a1dbae-5c8e-f0b8-e063-6294a90a44be
Set id: d2062094-d1b5-38ab-e053-2995a90a5670
Version: 2
Effective Time: 20231026
 
NORTHEAST PHARMA