DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
WALGREENS
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid ■ for relief of occasional sleeplessness ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin ■ a breathing problem such as emphysema, or chronic bronchitis ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland taking sedatives or tranquilizers sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Authorization status:
OTC monograph final
Authorization number:
0363-9895-48

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule

WALGREENS

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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Diphenhydramine HCl USP 50 mg Gelcaps

Active ingredient

(in each gelcap)

Diphenhydramine HCl USP 50 mg

Purpos e

Nighttime sleep-aid

Us es

■ for relief of occasional sleeplessness

Warnings

Do Not Use

■ for 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

■ a breathing problem such as emphysema, or chronic bronchitis

■ glaucoma

■ difficulty in urination due to enlargement of the 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 the reach of children

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

Directions

adults & children 12 years of age and over: 1 gelcap (50 mg) 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, polyethylene glycol, 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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-9 8 9 5

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

TALC (UNII: 7SEV7J4R1U)

AMMO NIA (UNII: 5138 Q19 F1X)

WALGREENS

AMMO NIA (UNII: 5138 Q19 F1X)

XANTHAN GUM (UNII: TTV12P4NEE)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

BUTYL ALCO HO L (UNII: 8 PJ6 1P6 TS3)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

GELATIN (UNII: 2G8 6 QN327L)

HYDRO XYPRO PYL CELLULO SE, UNSPECIFIED (UNII: 9 XZ8 H6 N6 OH)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

Product Characteristics

Color

blue, gray

S core

no sco re

S hap e

CAPSULE

S iz e

16 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-9 8 9 5-48

48 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/20 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt338

0 7/20 /20 17

Labeler -

WALGREENS (008965063)

Revised: 4/2019

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