Rugby Mucus Relief Er Tablet, Multilayer, Extended Release
FDA Label NDC 0536-1489

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Mucus Relief Er (NDC 0536-1489). 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 active ingredient (in each extended-release tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, 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

Active Ingredient (In Each Extended-Release Tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Do Not Use

  • for children under 12 years of age

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • do not crush, chew, or break extended-release tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Rugby®

compare to the active ingredient in Mucinex® Extended Release Tablets 600 mg

mucus relief ER

guaifenesin 600 mg extended-release tablets

expectorant

• relieves chest congestion

• thins and loosens mucus

• immediate and extended release

12 hour

40 extended-release tablets

actual size

Rugby-mucus-relief-er-carton-image.jpg (Rugby Mucus Relief Er Carton Image)

Rugby-mucus-relief-er-carton-image.jpg (Rugby Mucus Relief Er Carton Image)

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