SLEEP AID NIGHTTIME- diphenhydramine hcl liquid

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

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid - for the relief of occasional sleeplessness - reduces time to fall asleep if you have difficulty falling asleep
Authorization status:
OTC monograph final
Authorization number:
55910-899-12

SLEEP AID NIGHTTIME- diphenhydramine hcl liquid

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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.

----------

Drug Facts

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 mg

Purpos e

Nighttime sleep-aid

Us es

for the 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

Ask a doctor before use if you have

a breathing problem such as emphysema 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 or any other sleep-aid.

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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

take only one dose per day (24 hours)

mL=milliliter

keep dosing cup with product

measure only with dosing cup provided. Do not use any other dosing device

adults and children 12 years and over

one dose=30 mL at bedtime if needed, or as directed by a doctor

children under 12 years do not use

Other information

each 30 mL contains: sodium 22 mg

store between 20-25ºC (68-77ºF). Do not refrigerate

protect from light

Inactive ingredients

citric acid, alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40

stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, sodium citrate

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient of ZZZQUIL®*

Night Time

Sleep Aid

Diphenhydramine HCI 50 mg

Nighttime Sleep-Aid

Non-habit forming

Not For Pain

Not For Colds

ALCOHOL 10%

Vanilla Cherry Flavor

FL OZ (mL)

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP

OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a

registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Package Label

DOLLAR GENERAL Nig httime Sleep-Aid

SLEEP AID NIGHTTIME

diphenhydramine hcl liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -8 9 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

50 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

PO LYO XYL 4 0 STEARATE (UNII: 13A4J4NH9 I)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SACCHARIN SO DIUM ANHYDRO US (UNII: I48 0 7BK6 0 2)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)

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

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

VANILLA (CHERRY)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:559 10 -8 9 9 -

355 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/31/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt338

0 3/31/20 18

Labeler -

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 4/2019

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