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Diphenhydramine Hydrochloride by WALGREENS

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: WALGREENS
NDC Code: 0363-9895

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.

Diphenhydramine HCl USP 50 mg Gelcaps

Active ingredient

(in each gelcap)

Diphenhydramine HCl USP 50 mg

Purpose

Nighttime sleep-aid

Uses

■ for relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep.

Warnings

Do Not Use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin

■ with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

■ a breathing problem such as asthma, emphysema, or chronic bronchitis

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

■ heart disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid

When using this product

■ avoid alcoholic beverages and other drugs that cause drowsiness

■ drowsiness will occur

■ be careful when driving a motor vehicle or operating machinery

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 the reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults & children under 12 years and over: 1 gelcap at bedtime if needed or as directed by a doctor

Other information

■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.

■ avoid high humidity

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C Red #33, dicalcium phosphate dihydrate, FD&C Blue #1, FD&C Yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, N-butyl alcohol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Diphenhydramine HCl 50mg

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9895
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 
TITANIUM DIOXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
PROPYLENE GLYCOL 
TALC 
AMMONIA 
XANTHAN GUM 
ISOPROPYL ALCOHOL 
FERROSOFERRIC OXIDE 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
D&C RED NO. 33 
BUTYL ALCOHOL 
SHELLAC 
SILICON DIOXIDE 
GELATIN 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL, UNSPECIFIED 
CROSCARMELLOSE SODIUM 
LECITHIN, SOYBEAN 
Product Characteristics
Colorblue, grayScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeG16
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-9895-4848 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33807/20/2017
Labeler - WALGREENS (008965063)

 
WALGREENS

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Medically reviewed on Jul 20, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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