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Drug Facts
Leader Nighttime Sleep-aid Liquid
FDA Label NDC 70000-0174
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Nighttime Sleep-aid (NDC 70000-0174). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 30 ml dose cup), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
Berry flavor
Naturally & Artificially Flavored
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®.
Leader Nighttime Sleep Aid Berry Flavor 12fl Oz 354 mL (Image 01)
* Please review the disclaimer below.
