Drug Facts
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Dr Kids Chewable Gel
FDA Label NDC 73282-2533
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 73282-2533). 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, ask a doctor or pharmacist before use if your child is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient And Purpose
.
Otc - Purpose
| Active ingredient (in each chewable) | Purposes |
| Acetaminophen 80 mg............... | Pain reliever/ fever reducer |
Uses
For the temporary relief of minor aches and pains due to
■ a common cold/ flu
■ sore throat
■ headache
■ and to reduce fever
Warnings
Liver warning: This product contains Acetaminophen. Severe liver damage may occur if your child takes
■ more than 5 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing Acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening
■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help immediately.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
■ with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask A Doctor Before Use If Your Child Has
■ liver disease
Ask A Doctor Or Pharmacist Before Use If Your Child Is
■ taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
■ pain gets worse or lasts more than 5 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ any new symptoms appear
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). Prompt medical attention is critical even if you do not notice any signs or symptoms.
Directions
■ this product does not contain directions or complete warnings for adult use
■ do not exceed 5 doses in a 24-hour period (see liver warning)
■ use dose based on your child's weight or age
■ instruct child to chew thoroughly before swallowing
| Weight (lbs) | Age (years) | Dose* (chew) |
| under 24 | under 2 | do not use |
| 24-35 | 2 to under 4 | 2 |
| 36-47 | 4 to under 4 | 3 |
| 48-59 | 6 to under 9 | 4 |
| 60-71 | 9 to under 11 | 4 ot 5 |
| 72-95 | 11 | 4 to 6 |
*dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by 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, sucralose, sucrose
Questions Or Comments?
+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com
* Please review the disclaimer below.
