Drug Facts
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Calmco Chewable Gel
FDA Label NDC 73282-2529
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 73282-2529). 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 have, 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 | 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
■ 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 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 health professional 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).
Directions
■ do not exceed 12 chewables in a 24-hour period
■ chew thoroughly before swallowing
| Age | Dose (chew) |
adults and children 12 years and older | take 1-2 chewables every 4-6 hours |
| children under 12 years | do not use |
Other Information
■ store between 68-77°F (20-25°C) 20-25°C)
■ avoid high humidity and protect from light
■ do not use if foil seal under cap is torn, broken or missing
■ see bottom of bottle for lot number and expiration date
Inactive Ingredients
beta-cyclodextrin, carrageenan, corn syrup, flavors, purified water, sucrose, sucralose
Questions Or Comments?
+1-941-203-4509 (M-F) 9 AM - 5 PM EST or www.calmco.com
* Please review the disclaimer below.
