Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f2113abf-c1a3-42a6-a25e-e30a31fcad95
Route
ORAL
Published
Effective Date 2024-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Agave Tequilana Juice Citric Acid Monohydrate Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-30

Description

Dextromethorphan HBr USP, 5 mg Guaifenesin USP, 100 mg

Purpose

Antihistamine/Cough suppressant


Medication Information

Purpose

Antihistamine/Cough suppressant

Description

Dextromethorphan HBr USP, 5 mg Guaifenesin USP, 100 mg

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
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



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
Product Label
KINDERMED Kids Cough & Congestion Kids Nighttime Cold & Cough
Other Information

Daytime

  • store between 20-25ºC (68º-77ºF).
  • Do not refrigerate.

Nighttime

  • store between 20-25ºC (68-77ºF).
  • Do not refrigerate
  • protect from light
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

Purposes for Day Time

Cough suppressant

Expectorant

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)

DO NOT TAKE KIDS' COUGH & CONGESTION AND KIDS' NIGHTTIME COLD & COUGH AT THE SAME TIME.

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

.†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

 



Purposes for Night Time

Antihistamine/Cough suppressant

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.

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
Active Ingredient Daytime (in Each 5 Ml)

Dextromethorphan HBr USP, 5 mg

Guaifenesin USP, 100 mg

Active Ingredient Nighttime (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is

NIGHTTIME

taking sedatives or tranquilizers.


Structured Label Content

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
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



Do Not Use (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
Product Label
KINDERMED Kids Cough & Congestion Kids Nighttime Cold & Cough
Other Information (Other information)

Daytime

  • store between 20-25ºC (68º-77ºF).
  • Do not refrigerate.

Nighttime

  • store between 20-25ºC (68-77ºF).
  • Do not refrigerate
  • protect from light
Inactive Ingredients (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

Purposes for Day Time

Cough suppressant

Expectorant

Questions Or Comments? (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)

DO NOT TAKE KIDS' COUGH & CONGESTION AND KIDS' NIGHTTIME COLD & COUGH AT THE SAME TIME.

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

.†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

 



Purposes for Night Time

Antihistamine/Cough suppressant

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Ask A Doctor Before Use your Child Has (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
Active Ingredient Daytime (in Each 5 Ml) (Active ingredient Daytime (in each 5 mL))

Dextromethorphan HBr USP, 5 mg

Guaifenesin USP, 100 mg

Active Ingredient Nighttime (in Each 5 Ml) (Active ingredient Nighttime (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

NIGHTTIME

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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