Drugplain

LEADER Nighttime Sleep-Aid 50 mg/30mL

DIPHENHYDRAMINE HYDROCHLORIDE · LIQUID · CARDINAL HEALTH

No Recall History
Plain English

LEADER Nighttime Sleep-Aid is a prescription liquid containing diphenhydramine hydrochloride at 50 mg/30mL, taken oral. Manufactured by CARDINAL HEALTH.

Key Facts

Brand Name
LEADER Nighttime Sleep-Aid
Generic Name
DIPHENHYDRAMINE HYDROCHLORIDE
NDC Code (Product)
70000-0174
Manufacturer
CARDINAL HEALTH
Strength
50 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M010
Drug Class
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Marketing Start
03/13/2017

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue3,476 reports
off label use3,144 reports
pain3,111 reports
headache3,110 reports
drug ineffective2,809 reports
infusion related reaction2,770 reports
arthralgia2,703 reports
nausea2,683 reports
nasopharyngitis2,384 reports
pneumonia2,296 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is LEADER Nighttime Sleep-Aid used for?

LEADER Nighttime Sleep-Aid contains DIPHENHYDRAMINE HYDROCHLORIDE. It is a liquid taken oral. Consult your doctor for specific uses.

Is LEADER Nighttime Sleep-Aid a controlled substance?

LEADER Nighttime Sleep-Aid is not classified as a controlled substance by the DEA.

What is the generic name for LEADER Nighttime Sleep-Aid?

The generic name for LEADER Nighttime Sleep-Aid is DIPHENHYDRAMINE HYDROCHLORIDE. There are 12 other brand versions of DIPHENHYDRAMINE HYDROCHLORIDE.

What is the NDC code for LEADER Nighttime Sleep-Aid 50 mg/30mL?

The NDC (National Drug Code) for LEADER Nighttime Sleep-Aid 50 mg/30mL is 70000-0174, listed by CARDINAL HEALTH.