Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
CalmCo Sleep Aid Gummy Bite
- Manufacturer
- CalmCo LLC
- Effective date
- 2024-12-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:42:41
Label at a glance#
ProductCalmCo Sleep Aid Gummy Bite
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
take only 1 dose per day (24 hours) chew each piece thoroughly before swallowing Age (Yrs) Dose (per piece) adults and children 12 years and over 1 to 2 pieces (25 mg to 50 mg) children under 12 years do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient and Purpose
OTC - PURPOSE SECTION
| Active ingredient | Purpose |
| Diphenhydramine HCl 25 mg .................. | Nighttime sleep aid |
Warnings
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.
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
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.
Directions
- take only 1 dose per day (24 hours)
- chew each piece thoroughly before swallowing
| Age (Yrs) | Dose (per piece) |
adults and children 12 years and over | 1 to 2 pieces (25 mg to 50 mg) |
| children under 12 years | do not use |
Questions or Comments?
Call
941-203-4590 or visit 
www.calmco.com
Principal Display Panel
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73282-2518-1 | CalmCo Sleep Aid Gummy Bite | 25 in 1 BOTTLE, PLASTIC | BAR, CHEWABLE | 25 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 73282-2518 | CALMCO SLEEP AID GUMMY BITE (DIPHENHYDRAMINE HCL) BAR, CHEWABLE [CALMCO LLC] | 2 | Current NDC, 1 package rows | 20241215_0c534cbd-40e6-8af0-e063-6394a90a5605.zip |
Products#
Every source-derived product name is available through these pages.
- CalmCo Sleep Aid Gummy Bite
- Diphenhydramine HCl
- CARRAGEENAN
- STARCH, CORN
- MALTITOL
- GLYCERYL MONO AND DIPALMITOSTEARATE
- NEOTAME
- SODIUM CHLORIDE
- POVIDONE K30
- SUCRALOSE
- POLYETHYLENE GLYCOL 400
- TRISODIUM CITRATE DIHYDRATE
- PROPYLENE GLYCOL
- SUCROSE
- CORN SYRUP
- HYDROXYPROPYL BETADEX
- ACACIA
- WATER
- FD&C RED NO. 40
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73282-2518 | 73282-2518-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CalmCo Sleep Aid Gummy Bite | DIPHENHYDRAMINE HCL | CalmCo LLC | 0c534cbd-40e6-8af0-e063-6394a90a5605 | 2024-12-07 | Warnings | 73282-2518-1 73282-2518 73282251801 28b60a20-e53c-8ebe-e063-6394a90af031 0c534cbd-40e6-8af0-e063-6394a90a5605 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.