Drug Facts
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Dr Kids Chewable Gel
FDA Label NDC 73282-2531
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 Dr Kids (NDC 73282-2531). 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 your child has, 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 chew) | Purpose |
| Diphenhydramine HCl 12.5 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 Your Child Has
■ glaucoma
■ a breathing problem such as chronic bronchitis
■ is taking sedatives or tranquilizers
When Using This Product
■ may cause excitability in children
■ may cause marked drowsiness
■ sedatives and tranquilizers may increase the drowsiness effect
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 chewables in a 24-hour period
■ chew thoroughly before swallowing
| Age | Dose (chew) |
| children 6 to 12 years and older | take 1-2 chewables every 4 to 6 hours |
| children under 6 years | consult a doctor |
Other Information
■ store between 68-77°F (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.
