DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet

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

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Active ingredient:
(in each gelcap), Diphenhydramine HCl, USP 25 mg
Available from:
CVS PHARMACY, INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid ■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep ■ 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 ■ a breathing problem such as asthma, emphysema, or chronic bronchitis ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ heart disease ■ taking sedatives or tranquilizers or any other sleep-aid 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:
69842-299-23

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet

CVS PHARMACY, INC

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.

----------

Nighttime

Rapid Release Gelcaps

Sleep-Aid

DIPHENHYDRAMINE HCl, USP 25 mg

Non-habit forming**

Active ingredients

(in each gelcap)

Diphenhydramine HCl, USP 25 mg

Purpos e

Nighttime sleep-aid

Us es

■ for relief of occasional sleeplessness

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

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/u products

Ask a doctor before use if you have

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

■ glaucoma

■ difculty 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

Keep out of the reach of children

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or

contact a Poison Control Center right away.

Directions

take only one dose per day (24 hours) see overdose warning

adults & children 12 years and over

■ 2 gelcaps at bedtime if needed or as directed by a doctor

children under 12 years

■ do not use

Other information

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

■ avoid high humidity

Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #

28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxyl

propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, 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 HYDROCHLORIDE

diphenhydramine hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-29 9

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

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

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

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

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

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

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

AMMO NIA (UNII: 5138 Q19 F1X)

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

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TALC (UNII: 7SEV7J4R1U)

XANTHAN GUM (UNII: TTV12P4NEE)

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

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

SHELLAC (UNII: 46 N10 7B71O)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

GELATIN (UNII: 2G8 6 QN327L)

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

Product Characteristics

Color

gray (ENCAPSULATED WITH BLUE GRAY OPAQUE AND PURPLE OPAQUE HARD GELATIN

SHELLS)

S core

sc o re

S hap e

OVAL

S iz e

16 mm

Flavor

Imp rint

Cod e

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 8 42-29 9 -23

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

0 8 /18 /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 8 /18 /20 17

CVS PHARMACY, INC

Labeler -

CVS PHARMACY, INC (062312574)

Revised: 4/2019

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