Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 5b123501-cc51-42cd-b7b7-65833f44166b
Route
ORAL
Published
Effective Date 2024-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-29

Description

Dextromethorphan HBr USP, 5 mg Guaifenesin USP, 100 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr USP, 5 mg Guaifenesin USP, 100 mg

Uses
  • 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
Purposes

Cough suppressant

Expectorant

Question?

 Call 424-235-0355

Directions
  • 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


Do Not Use

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 taking this product.

Package Label
KINDERMED Kids Cough and Congestion Organic Berry Flavor
Other Information
  • store between 20-25ºC (68-77ºF).
  • do not refrigerate.
Inactive Ingredients

Organic agave syrup, non-GMO citric acid, glycerin, organic natural flavor, purified water

Principal Display Panel

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

NO DYES.

NO ARTIFICIAL FLAVORS.

NO ARTIFICIAL SWEETENERS.

DOSAGE CUP PROVIDED

FL OZ (mL)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277

kinderfarms.com

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr USP, 5 mg

Guaifenesin USP, 100 mg

Ask A Doctor Before Use If the Child Has
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Structured Label Content

Uses
  • 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
Purposes

Cough suppressant

Expectorant

Question? (QUESTION?)

 Call 424-235-0355

Directions
  • 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


Do Not Use (Do not use)

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 taking this product.

Package Label
KINDERMED Kids Cough and Congestion Organic Berry Flavor
Other Information (Other information)
  • store between 20-25ºC (68-77ºF).
  • do not refrigerate.
Inactive Ingredients (Inactive ingredients)

Organic agave syrup, non-GMO citric acid, glycerin, organic natural flavor, purified water

Principal Display Panel

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

NO DYES.

NO ARTIFICIAL FLAVORS.

NO ARTIFICIAL SWEETENERS.

DOSAGE CUP PROVIDED

FL OZ (mL)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277

kinderfarms.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr USP, 5 mg

Guaifenesin USP, 100 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Advanced Ingredient Data


Raw Label Data

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