Walgreen Solution
FDA Label NDC 0363-7296

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Walgreen (NDC 0363-7296). 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 other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each 20 mL)Purposes

Dextromethorphan HBr 20 mg

Cough suppressant

Guaifenesin 400 mg

Expectorant

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 you get to sleep

Otc - Do Not Use

Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Otc - When Using

When using this product do not use more than directed

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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 right away.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
  • children under 12 years of age: do not use

Other Information

  • each 20 mL contains: sodium 8 mg
  • store at room temperature
  • do not refrigerate

Inactive Ingredients

citric acid, D&C Yellow No. 10, disodium edetate, flavors, FD&C Red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel - 180 Ml Bottle Label

NDC 0363-7296-06

COUGH &
CHEST
CONGESTION

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus

    • Honey & Berry Flavor

    Naturally and Artificially Flavored

    6 fl oz (180 mL)

    For Ages 12+

    Tamper evident: Do not use if printed inner seal under cap is broken or missing.

    Maximum Strength per 4-hour dose

    Distributed by:

    Cough And Chest Congestion (Delsym 01)

    Cough And Chest Congestion (Delsym 01)

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