FDA Label for Daytime Nighttime Multi Symptom Cold Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR DAY TIME (IN EACH 5 ML)
- ACTIVE INGREDIENTS FOR NIGHT TIME (IN EACH 10 ML)
- PURPOSES FOR DAY TIME
- PURPOSES FOR NIGHT TIME
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Daytime Nighttime Multi Symptom Cold Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. 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 For Day Time (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Active Ingredients For Night Time (In Each 10 Ml)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purposes For Day Time
Cough suppressant
Expectorant
Nasal decongestant
Purposes For Night Time
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
Daytime
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- sneezing
- runny nose
- nasal congestion
- cough
- controls cough to help your child get to sleep
- temporarily reduces fever
Nighttime
Warnings
Nighttime only
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
- 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
DAYTIME
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- with 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.
- with any other drug containing diphenhydramine even one used on the skin
- if your child is allergic to acetaminophen or any of the inactive ingredients in thia product
- to make a child sleepy
NIGHTTIME
Ask A Doctor Before Use Your Child Has
DAYTIME
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such occurs with asthma
- liver disease
- heart disease
- high blood 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)
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If The Child Is
- taking sedatives or tranquilizers. (Nighttime only)
- taking the blood thinning drug warfarin
When Using This Product
Daytime
do not use more than directed.
Nighttime
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may ocur
- sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
DAYTIME
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better with 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
NIGHTTIME
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Nighttime
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 (1-800-222-1222). Quick medical attention is critical even if you not notice any signs or symptoms.
Directions
Daytime
- do not take more than 6 doses in any 24-hour period
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- keep dosing cup with product
- dose as follows or as directed by a doctor
- mL= milliliter
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see overdose warning)
- do not give more than 5 doses in any 24-hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctot
- measure only with dosing cup provided. Do not use any other dosing device
- mL = milliliter
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL every 4 hours
- children under 6 yearsof age: do not use
age | dose |
children 6 to under 12 years | 10 mL every 4 hours |
children 4 to under 6 years | 5 mL every 4 hours |
children under 4 years | do not use |
Nighttime
Other Information
Daytime
- each 5 mL contains: sodium 4 mg
- store between 20-25°C (68°-77°F). Do not refrigerate.
- each 5 mL contains: sodium 5 mg
- store at 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
Nighttime
Inactive Ingredients
Inactive ingredients for Day Time
anhydrous citric acid, EDTA disodium, FD&C red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
Inactive ingredients for Night Time
anhydrous citric acid, EDTA disdoium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
Principal Display Panel
Compare to Children's Mucinex DayTime Multi-Symptom Cold & Night Time Multi-Symptom Cold active ingredients††
Children's
Multi-Symptom Cold
DEXTROMETHORPAN HBr 5 mg / COUGH SUPPRESSANT
GUAIFENESIN 100 mg / EXPECTORANT
PHENYLEPHRINE HCI 2.5 mg / NASAL DECONGESTANT
DAYTIME
- Relief from chest congestion, cough & stuffy nose
- Breaks up mucus
- Relief from stuffy nose, cough, fever, sore throat, runny nose & sneezing
AGES 4 - 11 YEARS
BERRY FLAVOR
FL OZ (mL)
children's
Multi-Symptom Cold
ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
NIGHTTIME
AGES 6 - 11 YEARS
BERRY FLAVOR
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
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Day Time & Night Time Multi-Symptom Cold.
DISTRIBUTED BY; WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Product Label
WALGREENS Children's Multi-Symptom Cold DayTime Night Time Berry Flavor
* Please review the disclaimer below.