FDA Label for Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 10ML)
- PURPOSES
- 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
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL
Drkids Childrens Muti Symptom Cold Flu And Sore Throat Nighttime 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 Ingredients (In Each 10Ml)
Acetaminophen, 325mg
Diphenhydramine HCl, 12.5mg
Phenylephrine HCl, 5mg
Purposes
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Uses
■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sneezing ■ cough
■ controls cough to help your child get to sleep
■ 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 ■ with any other product containing diphenhydramine, even one used on the skin■ if 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.
Ask A Doctor Before 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 Doctor Or Pharmacist Before Use If Your Child Is
■ taking the blood thinning drug warfarin ■ taking any other nasal decongestant or stimulant ■ taking any other pain reliever/ fever reducer ■ 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 Warning
Taking more than the recommended dose (overdose) may cause liver damage. 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 warnings for adult use
■ do not give more than directed (see Overdose warning)
■ dose as follow or as directed by a doctor.
■ follow the instructions under "Easy to Use" on the side panel
■ empty all liquid in each Single-Use Vial when dosing
■ children 6 - 11 years of age: 1 single-use vial (10mL) every 4 hours while symptoms last; do not give more than 5 doses in any 24 hour period
■ children under 6 years of age: 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. |
Other Information
■ each Single -Use vial contains 11mg of sodium
■ store at 20-25°C (68-77°F)
■ do not refrigerate
■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.
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.
Questions Or Comments?
Call 941-202-3207 or visit www.DrKids.com
* Please review the disclaimer below.