3f156679-7a91-aff1-e063-6394a90a18f6 — v2

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Version

v2

Effective date

September 26, 2025

Original packager

Sections captured

18

Identifiers

Document ID
3fb7ac8e-8c41-8b84-e063-6394a90a15f2
Set ID
3f156679-7a91-aff1-e063-6394a90a18f6
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient and Purpose . Active ingredient (in each 5 mL vial) Purpose Dextromethorphan HBr 5mg.............. Cough supressant Guaifenesin 100mg............ Expectorant
Active Ingredient Table (1)

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

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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)
Do Not Use (1)

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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
Dosage And Administration (1)

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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
Dosage And Administration Table (1)

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Age (Years)Dose
Under 4consult a doctor
4 to under 61 vial every 4 hours
6 to under 121-2 vials every 4 hours
12 and older2-4 vials every 4 hours
Inactive Ingredient (1)

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Inactive ingredients anhydrous citric acid, carboxymethylcellulose, flavor, propylene glycol, sodium benzoate, saccharin sodium, sorbitol, sucralose, water
Indications And Usage (1)

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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
Keep Out Of Reach Of Children (1)

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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).
Other Safety Information (1)

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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
Package Label Principal Display Panel (1)

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Principal Display Panel PDP
Purpose (1)

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

Sequence 1

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

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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
Spl Product Data Elements (1)

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Dr Kids Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID SORBITOL SODIUM BENZOATE WATER PROPYLENE GLYCOL SUCRALOSE CARBOXYMETHYLCELLULOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN SACCHARIN SODIUM Mixed Berry
Spl Unclassified Section (1)

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Drug Facts .
Stop Use (1)

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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
Warnings (1)

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Warnings 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 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 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).