Rugby Cough Guaifenesin
FDA Label NDC 50436-1095

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unit Dose Services for the product Rugby Cough Guaifenesin (NDC 50436-1095). 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, active ingredient (in each 10 ml), purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Re-order No.370448

Rev.10/15

R-107

Active Ingredient (In Each 10 Ml)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Stop Use

Stop use and ask a doctor if cough last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 at 1-800-222-1222.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=milliliter
  • this adult product is not intended for use in children under 12 years of age
    • agedose

    adults and children 12 years and over

    10 mL-20 mL every 4 hours

    children under 12 years

    do not use

Other Information

  • each 10 mL contains:sodium 4 mg
  • store at 20-25°C (68-77°F).
  • alcohol-free

Inactive Ingredients

citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions?

1-866-467-2748

How Supplied

Product: 50436-1095

NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE

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