Guaifenesin 600 Mg Tablet
FDA Label NDC 25000-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Guaifenesin 600 Mg (NDC 25000-042). 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 section, otc - purpose section, indications & usage section, otc - do not use section, otc - ask doctor section, otc - stop use section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient Section

→ Otc - Purpose Section

→ Indications & Usage Section

→ Otc - Do Not Use Section

→ Otc - Ask Doctor Section

→ Otc - Stop Use Section

→ Otc - Pregnancy Or Breast Feeding Section

→ Otc - Keep Out Of Reach Of Children Section

→ Dosage & Administration Section

→ Storage And Handling Section

→ Inactive Ingredient Section

→ Otc - Questions Section

→ Principal Display Panel

Otc - Active Ingredient Section

For 600 mg:
Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg

For 1200 mg:
Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

Otc - Purpose Section

Purpose

Expectorant

Indications & Usage Section

Uses

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

Otc - Do Not Use Section

Do not use

• for children under 12 years of age

Otc - Ask Doctor Section

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)

Otc - Stop Use Section

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.

Otc - Pregnancy Or Breast Feeding Section

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

Otc - Keep Out Of Reach Of Children Section

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

Dosage & Administration Section

Directions

For 600 mg

• do not crush, chew, or break extended - release 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: 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

For 1200 mg

• do not crush, chew, or break extended - release 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: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours.
• children under 12 years of age: do not use

Storage And Handling Section

Other information

• store at 20-25°C (68-77°F)

Inactive Ingredient Section

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid