Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Childrens Plus Multi Symptom Cold Suspension
FDA Label NDC 0363-0034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Childrens Plus Multi Symptom Cold (NDC 0363-0034). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if your child is taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- nasal congestion
- stuffy nose
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if 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 The Child Has
- liver disease
- glaucoma
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- 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
- 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
- redness or swelling is present
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 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 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
- do not give more than 5 doses in any 24-hour peroid
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- 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
Compare to Children's Tylenol® Plus Multi-Symptom Cold active ingredients††
children's
Multi-Symptom
Cold
ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
CHLORPHENIRAMINE MALEATE /
ANTIHISTAMINE
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
PHENYLEPHRINE HCI /
NASAL DECONGESTANT
- Relieves aches, fever, sore throat, sneezing, cough, runny & stuffy nose
AGES 6 -11 YEARS
FL OZ (mL)
GRAPE FLAVOR
DOSAGE CUP PROVIDED
††This product is not manufactured or distributed bt McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Multi-Symptom Cold.
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: WALGREEN CO
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Package Label
WALGREENS Children's Multi-Symptom Cold Grape Flavor
* Please review the disclaimer below.
