Guaifenesin Extended-release Tablets 600mg And 1200mg

Guaifenesin Extended-release Tablets 600mg And 1200mg
SPL v3
SPL
SPL Set ID e6994e38-2a21-4bcf-e053-2995a90a0854
Route
ORAL
Published
Effective Date 2022-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Potato Magnesium Stearate Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Microcrystalline Cellulose Hypromellose 2910 (5 Mpa.s) Hypromellose 2910 (10000 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: G;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2022-08-19
Description

Guaifenesin 600 mg (for 600mg)

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg (for 600mg)

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


Do not use

  • for children under 12 years of age
Directions
  • do not crush, chew, or break 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 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
  • children under 12 years of age: do not use
Other Information

  • do not use if foil inner seal is broken or missing.
  • store between 20-25°C (68-77°F)
Active Ingredient(s)

Guaifenesin 600 mg (for 600mg)

Inactive Ingredients

carbomer homopolymer type B; hypromellos, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

Questions Or Comments


Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.



All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

Principal Display Panel

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.
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)

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Structured Label Content

Use(s) (USE(S))
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose (PURPOSE)

Expectorant

Warnings (WARNINGS)


Do not use

  • for children under 12 years of age
Directions (DIRECTIONS)
  • do not crush, chew, or break 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 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
  • children under 12 years of age: do not use
Other Information (OTHER INFORMATION)

  • do not use if foil inner seal is broken or missing.
  • store between 20-25°C (68-77°F)
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Guaifenesin 600 mg (for 600mg)

Inactive Ingredients (INACTIVE INGREDIENTS)

carbomer homopolymer type B; hypromellos, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

Questions Or Comments (QUESTIONS OR COMMENTS)


Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.



All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask Doctor If (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.
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

(1-800-222-1222)

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.078815 · Updated: 2026-03-14T23:11:00.469021