Active Ingredient Daytime (In Each 5 Ml)
Dextromethorphan HBr USP, 5 mg
Daytime Cough Congestion Nighttime Cold Cough Kit
FDA Label NDC 82673-901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kinderfarms, Llc for the product Daytime Cough Congestion Nighttime Cold Cough (NDC 82673-901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient daytime (in each 5 ml), active ingredient nighttime (in each 5 ml), purposes for day time, purposes for night time, uses, do not use, ask a doctor before use your child has, ask a doctor or pharmacist before use if the child is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient Nighttime (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Purposes For Day Time
Cough suppressant
Expectorant
Purposes For Night Time
Antihistamine/Cough suppressant
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
- 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
Nighttime
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
- 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
NIGHTTIME
Ask A Doctor Or Pharmacist Before Use If The Child Is
NIGHTTIME
taking sedatives or tranquilizers.
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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
- 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 |
| 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
| 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
Daytime
- store between 20-25°C (68°-77°F).
- Do not refrigerate.
- store between 20-25°C (68-77°F).
- Do not refrigerate
- protect from light
Nighttime
Inactive Ingredients
Day Time
Organic agave syrup, non-GMO citric acid, glycerin, organic natural flavors, purified water
Night Time
Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water
Questions Or Comments?
Call 424-235-0355
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
KINDERMED Day & Night Kids' Cough & Congestion Kids' Nighttime Cold & Cough
* Please review the disclaimer below.
