FDA Label for Drkids Childrens Pain And Fever
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH PIECE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- OTC - WHEN USING
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - ASK DOCTOR/PHARMACIST
- OVERDOSAGE
- DIRECTIONS
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Drkids Childrens 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.
Active Ingredient (In Each Piece)
Acetaminophen 80 mg
Purpose
Pain reliever, fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- temporarily reduces fever
the common cold
flu
headache
sore throat
toothache
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
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
Otc - Ask Doctor
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - Stop Use
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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if your child has liver disease
Overdosage
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children 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 give more than directed (see overdose warning)
- find right dose on chart below. If possible, use weight to dose; otherwise, use age
- Instruct child to chew each piece thoroughly before swallowing
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Dosage & Administration
Weight (lb) | Age (yr) | Dose (piece)* |
Under 24 | Under 2 years | Ask a doctor |
24-35 | 2-3 years | 2 pieces |
36-47 | 4-5 years | 3 pieces |
48-59 | 6-8 years | 4 pieces |
60-71 | 9-10 years | 5 piceces |
72-95 | 11 years | 6 pieces |
*or as directed by a doctor
Other Information
- each piece contains: sodium 6 mg. low sodium
- Store in a cool dry place between 20-25°C (68-77°F).
- Child Resistant Container; do not use if printed seal under cap is broken or missing.
Inactive Ingredients
ammonium glycyrrhizate, flavors, geleol mono and diglycerides, glucode syrup, maltitol solution, maltodextrin, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
Questions Or Comments?
Call 1-941-202-3270
* Please review the disclaimer below.