NIGHTTIME SLEEP AID BERRY FLAVOR- diphenhydramine hydrochloride liquid

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• ▪ 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
• ▪ difficulty in urination due to enlargement of the 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 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.

Overdose warning:

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

Directions

• ▪ take only one dose per day (24 hours)
• ▪ only use cup provided

• adults & children 12yrs & over:

  30 mL at bed time if needed or as directed by a doctor

• Children under 12 yrs:

  do not use

Other information

• ▪ each 30 mL dose contains: potassium 5 mg, sodium 10 mg
• ▪ store at room temperature

Inactive ingredients

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

DRx CHOICE®

NDC: 68163-730-06

Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid*

Sleep-Aid

Nighttime

DIPHENHYDRAMINE HCl

Non-Habit Forming

•   Makes you fall asleep fast
•   Alcohol-Free

BERRY FLAVOR

Naturally and Artificially Flavored

Not for Pain. Not for Colds Just for Sleep.

6 FL OZ (177 mL)

$1.99 AMAZING NEW VALUE!

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID  BERRY FLAVOR
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-730
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY (Naturally and Artificially)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-730-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/17/2019

Labeler - Raritan Pharmaceuticals Inc (127602287)