FDA Label for Multi Symptom Cold And Multi Symptom Nighttime Cold Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR NIGHTTIME (IN EACH 10 ML)
- ACTIVE INGREDIENTS FOR DAYTIME (IN EACH 5 ML)
- PURPOSE FOR NIGHTTIME
- PURPOSE FOR DAYTIME
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THESE PRODUCTS
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Multi Symptom Cold And Multi Symptom Nighttime Cold Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Target Corporation. 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 Nighttime (In Each 10 Ml)
Acetaminophen 325 mg
Diphenhydramine HCI 12.5 mg
Phenylephrine HCI 5 mg
Active Ingredients For Daytime (In Each 5 Ml)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Purpose For Nighttime
Pain reliever / fever reducer
Antihistamine / Cough suppressant
Nasal Decongestant
Purpose For Daytime
Cough suppressant
Expectorant
Nasal decongestant
Uses
Nighttime
- 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
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
- temporarialy 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
Daytime
Warnings
NIGHTTIME
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
Nighttime
- 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 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 skin.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product
- to make a child sleepy
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Daytime
Ask A Doctor Before Use If You Have
Nighttime
- liver disease
- heart disease
- thyroid disease
- diabetes
- glaucoma
- 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)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Daytime
Ask A Doctor Or Pharmacist Before Use If You Are
Nighttime
- taking the blood thinning drug warfain
- taking sedative or tranquilizers
When Using These Products
Nighttime
- do not use more than directed
- marked drowsiness may occur
- excitablity may occur, especially in children
- sedatives and tranquilizer may increase drowsiness
- do not use more than directed
Daytime
Stop Use And Ask A Doctor If
Nighttime
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or last more than 5 days
- redness or swelling is present
- new symptoms occurs
- 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 conditions.
- nervousness, dizziness or sleeplessness occur
- symptoms do not better within 7 days or occur with fever
- cough lasts more than 7 days, comes back or occur with a fever, rash, or headache that lasts. These could be signs of a serious condition.
Daytime
Keep Out Of Reach Of Children.
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 do not notice any sign or symptoms.
Daytime
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Nighttime
- 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 doctor
- 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 years of age: do not use
- do not take more than 6 doses in any 24-hours 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
Daytime
Age | Dose |
children 6 years to under 12 years | 10 mL every 4 hours |
children 4 years to under 6 years | 5 mL every 4 hours |
children under 4 years | do not use |
Other Information
Nighttime
- each 10 mL contains: sodium 5 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- each 5 mL contains: 4 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Daytime
Inactive Ingredients
Nighttime
citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Daytime
citric acid, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose xanthan gum
Questions Or Comments?
Call 1-800-910-6874
Principal Display Panel
NIGHTTIME
Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**
Children's
multi-symptom
Cold Relief
acetaminophen 325 mg (pain reliever / fever reducer)
diphenhydramine HCI 12.5 mg (Antihistamine-Cough Suppressant)
phenylephrine HCI 5 mg (Nasal Decongestant)
stuffy nose
cough
runny nose and sneezing
fever and sore throat
Berry Flavor
Dosage Cup Included
AGES 6 - 11 YEARS
FL OZ (mL)
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold
DAYTIME
Compare to active ingredients in Children's Mucinex® Multi-Symptom Cold*
Children's
daytime
multi-symptom cold relief
dextromethorphan HBr 5 mg (Cough Suppressant)
guaifenesin 100 mg (expectorant)
phenylephrine HCI 2.5 mg (Nasal Decongestant)
stuffy nose
cough
chest congestion
breaks up mucus
Berry Flavor
Dosage cup included
ages 4 to 11 years
FL OZ (mL)
Dist. by Target Corp., Minneapolis, MN 55403
©2017 Target Brands, Inc.
Product Label
TARGET Children's Nighttime Multi-Symptom Cold Relief, Children's Daytime Multi-Symptom Cold Relief
* Please review the disclaimer below.