Guaifenesin 1200 Mg Tablet, Extended Release
FDA Label NDC 43598-108

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Guaifenesin 1200 Mg (NDC 43598-108). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, stop use and ask doctor if, if pregnancy/breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Guaifenesin 600 mg (for 600mg)

Guaifenesin 1200 mg (for 1200 mg)

Purpose

Expectorant

Use(S)

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

Warnings

Applicable warning(s) in 201.66(c)(5)(i) and (ii)

Do Not Use

  • For children under 12 years age

Ask A Doctor Before Use If

  • 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 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 Pregnancy/Breastfeeding,

ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
  • adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours (for 1200 mg)
  • 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, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

Questions?

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

Principal Display Panel- 600Mg Carton

Guaifenesin Extended-Release Tablets 600 mg Carton Label

Principal Display Panel - 1200 Mg Carton

Guaifenesin Extended-Release Tablets 1200 mg Carton Label

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