FDA Label for Childrens Plus Multi Symptom Cold
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 5 ML)
- 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 TAKING
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Childrens Plus Multi Symptom Cold Product Label
The following document was submitted to the FDA by the labeler of this product Care One (american Sales Company). 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 5 Ml)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- cough
- headache
- sore throat
- sneezing and runny nose
- nasal congestion
- stuffy nose
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occurif your child takes:
- more than 5 doses (10 mL) 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
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). 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
Ask A Doctor Before Use If Your Child Has
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- liver disease
Ask A Doctor Or Pharmacist Before Use If Your Child Is Taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dose (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- pain, nasal congestion or cough gets worse or lasts for more than 5 days
- nervousness, dizziness or sleeplessness occurs
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
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 (1-800-222-1222) right away. Quick medical attention is critical for adultsas well as children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- mL=milliliter
- shake well before using
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- do not give more than 5 doses in any 24-hours period
- if needed, repeat dose every 4 hours while symptoms last
- find the right dose on chart below. If possible, use weight to dose, otherwise, use age.
Weight (lb) | Age (yr) | Dose (mL) |
48-95 | 6-11 | 10 mL |
36-47 | 4-5 | do not use unless directed by a doctor |
under 36 | under 4 | do not use |
Other Information
- store between 20-25°C (68-77°F)
- do not refrigerate.
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
For Ages 6-11 Years
Children's Multi-Symptom Cold
Pain Relief / Fever Reducer - ACETAMINOPHEN, 160 mg
Antihistamine - Chlorpheniramine Maleate, 1 mg
Cough Suppressant - Dextromethorphan HBr, 5 mg
Nasal Decongestant - Phenylephrine HCI, 2.5 mg
FOR RELIEF OF:
- Fever & Sore Throat
- Sneezing and Runny Nose
- Cough
- Stuffy Nose
Oral Suspension
Dosage Cup Provided
Grape Flavored
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY:
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949
Package Label
CAREONE Childrens Multi-Symptom Cold Grape Flavor
* Please review the disclaimer below.