Drug Facts

Active ingredient (in each 30 mL)

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
▪: 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 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:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.1-800-222-1222

Directions

▪: take only one dose per day (24 hours) – see Overdose warning
▪: Measure with dosing cup provided.


adults & children 12 yrs & over	One Dose = 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: sodium 23 mg
▪: store at room temperature
▪: protect from light. Does not meet USP <671>

Inactive ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

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PRINCIPAL DISPLAY PANEL

LEADER

NDC 70000-0174-2

Sleep Aid

Diphenhydramine HCl , 50 mg

Nighttime Sleep-Aid

COMPARE TO ZZZQUIL™ NIGHTTIME SLEEP-AID active ingredient*

100% Money Back Guarantee

Berry Flavor

Naturally & Artificially Flavored

: Non-Habit forming
: Alcohol- Free
: Not for Treating Cold or Flu
: See Warnings

6 FL OZ (177 mL)

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

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

Leader Nighttime Sleep Aid Berry Flavor 6 FL OZ 177mL

LEADER NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0174
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0174-2	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	03/13/2017

Labeler - CARDINAL HEALTH (063997360)

Sleep Aid Diphenhydramine HCl 50 mg Nighttime Sleep Aid Berry Flavor 6 FL OZ 177mL