FDA Label for Dr Kids Pain And Fever
View Indications, Usage & Precautions
Dr Kids Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Calmco Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| Active ingredient (in each 5 mL vial) | Purpose |
| Acetaminophen 160 mg............... | Pain reliever/fever reducer |
| Active ingredient (in each 5mL vial) | Purpose |
| Acetaminophen 160 mg..................... | Pain reliever/ fever reducer |
Uses
For the temporary relief of minor aches and pains due to
- 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 acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin redness blisters rash
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 drug 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
- edness 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)
- follow the “Easy to Use” instructions on the pouch
corresponds to your child’s age use the dose that
| Age (Years) | Dose* |
| under 2 | consult a doctor |
| 2 to under 6 | 1 vial (5 mL) |
| 6 to 11 | 2 vials (10 mL) |
*dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor.
Other Information
- each 5 mL vial contains: sodium 2 mg
- store between 68-77°F (20-25°C)
- do not use if pouch or vial is punctured, torn or open
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose, FD&C red #40, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol, sucralose, xylitol, water
Questions Or Comments?
+1 941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com
Distributed by: CalmCo LLC, Sarasota, FL 34240
* Please review the disclaimer below.
