Label: DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS- dextromethorphan hbr,guaifenesin,phenylephrine hcl,acetaminophen,diphenhydramine hcl, phenylephrine hcl kit
- NDC Code(s): 0363-4060-04, 0363-4070-04, 0363-4200-08
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 26, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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
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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
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
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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
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
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.
NIGHTTIME
- 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
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 as occurs with asthma
NIGHTTIME
- liver disease
- heart disease
- high blood pressure
- 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)
Ask a doctor or pharmacist before use if the child is
NIGHTTIME
- taking sedatives or tranquilizers
- 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 occur
- 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.These could be signs of a serious condition.
NIGHTTIME
- 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.
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
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
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
- Other information
-
Inactive ingredients
Inactive ingredients for 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
Inactive ingredients for 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
- Questions or comments?
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Principal Display Panel
Compare to the active ingredients in Children's Mucinex DayTime Multi-Symptom Cold & Night Time Multi-Symptom Cold††
Children's
MULTI-SYMPTOM COLD
DEXTROMETHORPAN HBr 5 mg / COUGH SUPPRESSANT
GUAIFENESIN 100 mg / EXPECTORANT
PHENYLEPHRINE HCI 2.5 mg / NASAL DECONGESTANT
DAYTIME
ALCOHOL FREE
- Relief from chest congestion, cough & stuffy nose
- Breaks up mucus
AGES 4 - 11 YEARS
Berry flavor
FL OZ (mL)
children's
MULTI-SYMPTOM
ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
NIGHTTIME
ALCOHOL FREE
- Relief from stuffy nose, cough, fever, sore throat, runny nose & sneezing
AGES 6 - 11 YEARS
Berry flavor
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 Time Multi-Symptom Cold and Children's Mucinex® Multi-Symptom Cold.
DISTRIBUTED BY; WALGREEN CO.
DEERFIELD, IL 60015
walgreens.com
©2021 Walgreen Co.
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME MULTI SYMPTOM COLD CHILDRENS
dextromethorphan hbr,guaifenesin,phenylephrine hcl,acetaminophen,diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4200 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4200-08 1 in 1 KIT; Type 0: Not a Combination Product 12/31/2014 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 DAYTIME MULTI SYMPTOM COLD CHILDRENS
dextromethorphan hbr,guaifenesin,phenylephrine hcl liquidProduct Information Item Code (Source) NDC:0363-4070 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 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:0363-4070-04 118 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 12/31/2014 Part 2 of 2 NIGHTTIME MULTI SYMPTOM COLD CHILDRENS
acetaminophen,diphenhydramine hcl,phenylephrine hcl liquidProduct Information Item Code (Source) NDC:0363-4060 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 [arb'U] in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 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:0363-4060-04 118 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 12/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/31/2014 Labeler - Walgreens (008965063)
