Leader nighttime sleep-aid liquid

Spl unclassified section

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

Otc - ask doctor/pharmacist section

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

Otc - stop use section

Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding, ask a health professional before use.

Otc - keep out of reach of children section

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

Ingredients and appearance - Product information

Leader nighttime sleep-aid liquid- Diphenhydramine hydrochloride

Product information

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

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
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 Flavor BERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part338 USA

Labeler - CARDINAL HEALTH( 097537435)

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)

©2017 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.com1-800-200-6313

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