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 Dolgencorp, Inc. (dollar General & Rexall). 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
- stuffy nose
- temporarily reduces fever
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs contaning acetaminophen
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- 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 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) immediately. 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
- 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 times in 24 hours
- 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 at 20-25°C (68-77°F)
- do not refrigerate
Inactive Ingredients
carboxymethylcellulose sodium, citric acid, 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 1-888-309-9030
Principal Display Panel
Ages 6 to 11 years
Children's Plus Multi-Symptom Cold
Acetaminophen
Chlorpheniramine Maleate
Dextromethorphan HBr
Phenylephrine HCl
Oral Suspension
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
*Compare to active ingredients in Children's Tylenol® Plus Multi-Symptom Cold
Grape Flavored
Relieves:
Fever
Sore Throat
Sneezing
Runny Nose
Cough
Stuffy Nose
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Package Label
Dollar General Children's Plus Multi Symptom Cold Suspension
* Please review the disclaimer below.