Drug Facts
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Calmco Solution
FDA Label NDC 73282-2524
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 73282-2524). 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, otc - purpose, uses, warnings, do not use, ask a doctor before use if you, when using this product, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each 10 mL vial) | Purpose |
| Diphenhydramine HCl 25 mg............... | Antihistamine |
Uses
Temporarily relieves
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- other upper respiratory allergies
Warnings
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Do Not Use
- 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
- have glaucoma
- have trouble urinating due to an enlarged prostate gland
- are taking sedatives or tranquilizers
When Using This Product
- avoid consuming alcohol beverages
- may cause marked drowsiness
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 exceed 12 vials in a 24-hour period
- follow the “Easy to Use” instructions on pouch
| Age | Dose |
| Adults and children 12 years of age and older | take 1 - 2 vials every 4-6 hours |
| children under 12 years of age | do not use |
Other Information
- each 10 mL vial contains: sodium 4mg
- 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.
