Nighttime Sleep-Aid Non-Habit Forming
Nighttime Sleep-Aid Non-Habit Forming is an FDA drug label for the active ingredient DIPHENHYDRAMINE HCI manufactured by AptaPharma Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231230.
- Generic name
- DIPHENHYDRAMINE HCI
- Manufacturer
- AptaPharma Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 76281-522
- Application
- M017
- Label effective
- 20231230
Active ingredients
Indications & Usage
Uses ■ reduces time to fall asleep if you have difficulty falling asleep ■ for relief of occasional sleeplessness
Dosage & Administration
Directions ■ take only as recommended ■ Use dosage cup or tablespoon Age Dose Adults & children 12 One Dose = 2 tablespoons (30 mL) at bed years & over time if needed or as directed by a doctor
Contraindications
Not available.
Warnings
Warnings Do not use ■ for children under 12 years of age. ■ with any other product containing diphenhydramine, even one used on skin ■ with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products
Adverse Reactions
Not available.