Active Ingredient (In Each Piece)
Diphenhydrarnine HCI 25 mg
Calmco Sleep Aid Gummy Bite Bar, Chewable
FDA Label NDC 73282-2518
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Calmco Llc for the product Calmco Sleep Aid Gummy Bite (NDC 73282-2518). 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 (in each piece), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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 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
Ask A Doctor Before Use If You Have
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
- Trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
avoid alcoholic drinks
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- Take only 1 dose per day (24 hours)
- Chew each piece thoroughly before swallowing
Dosage Chart
| Age (Years) | Dose (Piece) |
| Adults and children 12 years and over | 1 to 2 pieces (25 mg to 50 mg) |
| children under 12 years | Do not use |
Other Information
- Each piece: contains sodium 9 mg. low sodium
- Store in a cool dry place between 20-25°C (68-77°F).
- Child Resistant Container; do not use if printed seal under cap is broken or missing.
Inactive Ingredients
FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
Questions Of Comments?
Call 941-203-4590 or visit www.calmco.com
* Please review the disclaimer below.
