Drug Facts
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Calmco Solution
FDA Label NDC 73282-2525
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 (NDC 73282-2525). 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 drug facts, active ingredient and purpose, otc - purpose, uses, warnings, do not use, ask a doctor before use if you, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient And Purpose
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Otc - Purpose
| Active ingredient (in each 10 mL vial) | Purpose |
| Diphenhydramine HCl 25 mg............... | Nighttime sleep-aid |
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
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Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- on children under 12 years of age
Ask A Doctor Before Use If You
- have a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- have trouble urinating due to an enlarged prostate gland
- are taking sedatives or tranquilizers
When Using This Product
avoid consuming alcohol beverages
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 Breastfeeding,
ask a healthcare professional before use
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- do not take more than directed
- follow the “Easy to Use” instructions on pouch
| Age | Dose |
| Adults and children 12 years and older | take 2 vials at bedtime, if needed |
| children under 12 years | do not use |
Other Information
- each 10 mL vial contains: sodium 4 mg
- store between 68-77°F (20-25°C)
- do not use if pouch has been torn open or vial is punctured or open
Inactive Ingredients
Anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, water, xylitol
Questions Or Comments?
+1 941-203-4590 (M-F) 9am-5pm EST or visit www.calmco.com
Distributed by: CalmCo LLC, Sarasota, FL 34240
Made in Dominican Republic
* Please review the disclaimer below.
