| NDC | 11673-420-08, 11673-704-04, 11673-806-04 |
| Set ID | e3da3003-88e3-4431-8b65-e61e17728901 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | TARGET Corporation |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients for Nighttime (in each 10 mL)
- Active ingredients for Daytime (in each 5 mL)
- Purpose for Nighttime
- Purpose for Daytime
-
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
Daytime
- 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
-
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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
Daytime
- 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.
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)
Daytime
- 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
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
Daytime
- do not use more than directed
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.
Daytime
- 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.
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
Daytime
- 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
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
-
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?
-
Principal Display Panel
NIGHTTIME
Compare to active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold*
Children's night time
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)
relieves
stuffy nose
cough
runny nose and sneezing
fever and sore throat
alcohol free
BERRY FLAVOR
DOSING CUP INCLUDED
AGES 6 - 11 YEARS
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
**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 HCl 2.5 mg (Nasal Decongestant)
relieves stuffy nose
controls cough
chest congestion
breaks up mucus
alcohol free
BERRY FLAVOR
DOSING CUP INCLUDED
AGES 4 to 11 YEARS
FL OZ (mL)
Distributed by Target Corporation
Minneapolis, MN 55403
- Product Label
-
INGREDIENTS AND APPEARANCE
MULTI SYMPTOM COLD AND MULTI SYMPTOM NIGHTTIME COLD CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-420 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-420-08 1 in 1 KIT; Type 0: Not a Combination Product 02/28/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 MULTI SYMPTOM COLD DAYTIME CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hci liquidProduct Information Item Code (Source) NDC:11673-704 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-704-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/28/2017 Part 2 of 2 MULTI SYMPTOM NIGHTTIME COLD CHILDRENS
acetaminophen, diphenhydramine hci, phenylephrine hci liquidProduct Information Item Code (Source) NDC:11673-806 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-806-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/28/2017 Labeler - TARGET Corporation (006961700)
