FDA Label for Drkids Children Multi Symptom Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 10ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFRE USE IF YOUR CHILD HAS
- ASK A COTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OVERDOSE SECTION
- DIRECTIONS
- INACTIVE INGREDIENTS
- OTHER INFORMATION
- QUESTIONS OR COMMENTS
- PACKAGE
Drkids Children Multi Symptom Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Calmco. 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 10Ml)
Acetaminophen, 320mg
Chlorpheniramine Maleate, 2mg
Dextromethorphan HBr, 10mg t
Phenylephrine HCl, 5mg
Purpose
Pain reliever / fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
■ temporarily relieves the following cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough■ stuffy nose
■ sneezing and runny nose ■ temporarily reduces 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 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
■ to make a child sleepy
■ in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
■ if your child has is allergic to any of the ingredients in this product
Ask A Doctor Befre Use If Your Child Has
■ liver disease ■ high blood pressure ■ heart disease ■ diabetes ■ thyroid disease ■ glaucoma ■ a breathing problem such as chronic bronchitis ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)
Ask A Cotor Or Pharmacist Before Use If Your Child Is
■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
When Using This Product
■ do not exceed recommended dosage (see overdose warning)
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ sedatives and tranquilizers may increase the drowsiness effect
Stop Use And Ask A Doctor If
■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Overdose Section
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms
Directions
■ this product does not contain directions or complete warning for adult use
■ do not give more than directed (see overdose warning)
■ find right dosage on chart below
■ empty each Single-Use Vial of all liquid when dosing, following the instructions under "Easy to use" on the side panel
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ children under the age of 6, do not use
Dosing Chart
Age (Years) | Dose (mL) |
6 - 11 years | 1 Single use vial (10mL) every 4 hours. Do not give more than 5 times in 24 hours |
Inactive Ingredients
citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.
Other Information
■ each Single -Use vial contains 11mg of sodium
■ store at 20-25°C (68-77°F)
■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.
Questions Or Comments
Call 941-202-3207 or visit www.drkids.com
* Please review the disclaimer below.