LEADER NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

LEADER Nighttime Sleep-Aid by

Drug Labeling and Warnings

LEADER Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. 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
• ▪ 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 (2 tablespoons) 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 70000-0174-1

Nighttime Sleep-aid

Diphenhydramine HCl

COMPARE TO ZZZQUIL® active ingredient*

100% money Back Guarantee

•   Non-habit forming

Berry flavor

Naturally & Artificially Flavored

•   Non-habit forming

12 FL OZ (354 mL)

©2016 Cardinal Health, All Rights Reserved CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal health.

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®.

INGREDIENTS AND APPEARANCE

LEADER NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0174
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	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0174-1	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	01/17/2017

Labeler - CARDINAL HEALTH (097537435)