Active Ingredient
(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg
Instarelief Nighttime Sleep Aid Liquid
FDA Label NDC 71598-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dxm Pharmacuetical, Inc. for the product Instarelief Nighttime Sleep Aid (NDC 71598-120). 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 active ingredient, purpose, uses, warning, dosage & administration, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Uses
- For relief of occasional sleeplessness.
- Helps to reduce difficulty falling asleep.
- Reduces time to fall asleep. Warnings
Warning
Do not use
- for children under 12 years of age, or
- with any other product containing diphenhydramine, even one used on skin.
- if you have a breathing problem such as emphysema or chronic bronchitis, or
- if you have glaucoma, or
- difficulty in urination due to enlargement of the prostate gland.
Do not take this product, unless directed by a doctor
Do not take this product ifyou are taking sedatives or tranquilizers, without first consulting your doctor. Avoid alcoholic beverages while taking this product. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding, ask a doctor before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosage & Administration
Directions
- only use this product according to these directions or as directed by a doctor
- do not exceed 1 dose (3 mL) (50 mg) in any24-hour period
- measure only 3 mL with dosing syringe provided
- keep dosing syringe with product
- mL = milliliter - fl oz = fluid ounce
| age | dose |
| adults and children 12 years and over | 3mL at bedtime |
| children under 12 years | do not use |
Other Information
TAMPER EVIDENT: Do not use if seal on the bottle is broken.
store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose
Questions Or Comments?
Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.InstaRelief.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.
* Please review the disclaimer below.
