Gnp Mucus Relief Tablet
FDA Label NDC 46122-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corp for the product Gnp Mucus Relief (NDC 46122-700). 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 otc - active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, 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

Otc - Active Ingredient

Active ingredient - (per tablet)

Guaifenesin   400 mg

Phenylephrine HCl  10 mg

Purpose

Guaifenesin.......................Expectorant

Phenylephrine HCl..............Nasal decongestant

Uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

  • helps loosen phlegm (mucus)
  • clear nasal passageways
  • loosens nasal congestion
  • drain bronchial tubes
  • shrinks swollen membranes
  • clears stuffy nose
  • makes coughs more productive
  • thin bronchial secretions

Warnings

Do not exceed recommended dosage

Do Not Use

This product 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 are uncertain whether your prescription drug contains an MAOI, ask a health
professional.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm;mucus
  • difficulty in urination due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur.

    • 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 the reach of children. In case of overdose, get medical help or contact a Poison
Control Center immediately.

Directions

  • adults and children 12 years and over: take 1 caplet every 4 hours as needed
  • children 6 to under 12 years: take 1/2 caplet every 4 hours as needed
  • children under 6 years: consult a doctor

    • Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Inactive Ingredients

croscarmellose sodium, Hypromellose, lactose, magnesium silicate, magnesium stearate maltodextrin, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

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