Label: LEADER NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid
- NDC Code(s): 70000-0174-1
- Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 26, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 30 mL dose cup)
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
- 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.
- Other information
- Inactive ingredients
PRINCIPAL DISPLAY PANEL
COMPARE TO ZZZQUIL® active ingredient*
100% money Back Guarantee
- Non-habit forming
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
*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 (063997360)