Drkids Children's Cough And Chest Congestion (a)

Drkids Children's Cough And Chest Congestion (a)
SPL v3
SPL
SPL Set ID 3f156679-7a91-aff1-e063-6394a90a18f6
Route
ORAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Sorbitol Sodium Benzoate Water Propylene Glycol Sucralose Carboxymethylcellulose Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

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Purpose

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Medication Information

Purpose

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Description

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Uses
  • temporarily relieves cough due to minor bronchial irritation associated with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 55105-1
Active ingredient (in each 5 mL vial) Purpose
Dextromethorphan HBr 5mg.............. Cough supressant
Guaifenesin 100mg............ Expectorant

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not exceed 6 doses in a 24-hour period
  • follow the “Easy to Use” instructions on the pouch
  • use the dose that corresponds to your child’s age
  • discard unused portion

Age (Years)

Dose
Under 4 consult a doctor
4 to under 6 1 vial every 4 hours
6 to under 12 1-2 vials every 4 hours
12 and older 2-4 vials every 4 hours

Do Not Use
  • if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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
Drug Facts

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Other Information
  • each 5 mL vial contains: sodium 7 mg
  • store between 68-77°F (20-25°C)
  • do not use if pouch or vial is punctured, torn or open
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose, flavor, propylene glycol, sodium benzoate, saccharin sodium, sorbitol, sucralose, water

Questions Or Comments?

+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Made in Dominican Republic

Principal Display Panel

Active Ingredient and Purpose

.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If Your Child Has
  • a persistent or chronic cough such as occurs with asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Stop Use and Ask A Doctor If Your Child Has
  • a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Structured Label Content

Uses
  • temporarily relieves cough due to minor bronchial irritation associated with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 55105-1 (55105-1)
Active ingredient (in each 5 mL vial) Purpose
Dextromethorphan HBr 5mg.............. Cough supressant
Guaifenesin 100mg............ Expectorant

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not exceed 6 doses in a 24-hour period
  • follow the “Easy to Use” instructions on the pouch
  • use the dose that corresponds to your child’s age
  • discard unused portion

Age (Years)

Dose
Under 4 consult a doctor
4 to under 6 1 vial every 4 hours
6 to under 12 1-2 vials every 4 hours
12 and older 2-4 vials every 4 hours

Do Not Use (Do not use)
  • if your child is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two 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
Drug Facts

.

Other Information (Other information)
  • each 5 mL vial contains: sodium 7 mg
  • store between 68-77°F (20-25°C)
  • do not use if pouch or vial is punctured, torn or open
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose, flavor, propylene glycol, sodium benzoate, saccharin sodium, sorbitol, sucralose, water

Questions Or Comments? (Questions or comments?)

+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Made in Dominican Republic

Principal Display Panel

Active Ingredient and Purpose

.

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

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

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)
  • a persistent or chronic cough such as occurs with asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Stop Use and Ask A Doctor If Your Child Has (Stop use and ask a doctor if your child has)
  • a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

Advanced Ingredient Data


Raw Label Data

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