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 aretaking 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 ifsleeplessness 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?

1-866-467-2748

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.com1-800-200-6313

*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 Drug	M010	03/13/2017

Labeler - CARDINAL HEALTH (063997360)

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