Label: DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH- dextromethorphan hbr, guaifenesin, diphenhydramine hcl kit
- NDC Code(s): 82673-102-04, 82673-191-04, 82673-901-08
- Packager: KinderFarms, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Daytime (in each 5 mL)
- Active ingredient Nighttime (in each 5 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
Nighttime
- temporarily relieves:
- sneezing
- runny nose
- itching of the nose or throat
- itchy, watery eyes due to hay fever or other upper respiratory allergies
- the impulse to cough
- cough to help you get to sleep
- cough due to minor throat and bronchial irritation as may occur with cold or inhaled irritants
- the intensity of coughing
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Warnings
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
- in a child under 4 years of age
- with any other product containing diphenhydramine even one used on the skin
- for the purpose of making your child sleepy
Ask a doctor before use your child has
DAYTIME
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such occurs with asthma
NIGHTTIME
- glaucoma
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occur with smoking, asthma, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
When using this product
Nighttime
- do not exceed recommended dosage
- marked drowsiness may occur
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
DAYTIME
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
cough persists for more than 1 weeks, tend to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
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Directions
Daytime
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
age dose children 6 to under 12 years 5-10 mL every 4 hours children 4 to under 6 years 2.5-5 mL every 4 hours children under 4 years do not use
Nighttime- adults and children 6 years and over: do not exceed more than 6 doses in 24 hour unless directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- shake well before using
- mL = milliliter
Age
Dose
adults and children 12 years of age and over
10 mL every 4 hours
children 6 to under 12 years of age
5 mL every 4 hours
children 4 to under 6 years of age
do not use unless directed by a doctor
children under 4 years of age
do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Same active ingredients as Mucinex Children's® Cough†
KIDS' COUGH & CONGESTION Ages 4-11 yrs
Dextromethorphan HBr 5 mg per 5 mL
Cough Suppressant
Guaifenesin 100 mg per 5 mL
Expectorant
Organic Berry Flavor
DOSING CUP INCLUDED
FL OZ (mL)
keep outer carton for complete warnings and product information
KIDS' Ages 6+
NIGHTTIME
COLD & COUGH
Diphenhydramine HCl 12.5 mg per 5 mL
Antihistamine/Cough Suppressant
Organic Cherry Flavor
DOSING CUP INCLUDED
fl oz (mL)
Keep outer carton for complete warnings and product information.
TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.
DO NOT TAKE KIDS' COUGH & CONGESTION AND KIDS' NIGHTTIME COLD & COUGH AT THE SAME TIME.
†THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY RB HEALTH (us) LLC, DISTRIBUTOR OF MUCINEX CHILDREN'S® COUGH
DISTRIBUTED BY: KinderFarm®
Redondo Beach, CA 90277
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH
dextromethorphan hbr, guaifenesin, diphenhydramine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82673-901 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82673-901-08 1 in 1 KIT; Type 0: Not a Combination Product 05/30/2024 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 MUCUS RELIEF COUGH AND CONGESTION CHILDRENS
dextromethorphan hbr, guaifenesin liquidProduct Information Item Code (Source) NDC:82673-102 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 Inactive Ingredients Ingredient Name Strength AGAVE TEQUILANA JUICE (UNII: GVG8G0207O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82673-102-04 1 in 1 BOX 1 118 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 Drug M012 05/30/2024 Part 2 of 2 NIGHTTIME COLD AND COUGH
diphenhydramine hcl liquidProduct Information Item Code (Source) NDC:82673-191 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength AGAVE TEQUILANA JUICE (UNII: GVG8G0207O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82673-191-04 1 in 1 BOX 1 118 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 Drug M012 05/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/30/2024 Labeler - KinderFarms, LLC (075458767)
