Mucus Relief 600mg

Mucus Relief 600mg
SPL v5
SPL
SPL Set ID b2e85973-2179-5a21-e053-2a95a90ad6bb
Route
ORAL
Published
Effective Date 2020-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Hypromellose, Unspecified Cellulose, Microcrystalline Povidone, Unspecified Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Pill Appearance
Imprint: G233 Shape: capsule Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2019-09-23

Description

Guaifenesin 600 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg

Use(s)

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

Warning

.

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: 1 or 2 tablets every 12 hours.  
  • Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use
Do Not Use

for children under 12 years of age

Questions?

1-800-616-2471

You may also report side effects to this phone number. 

Other Information
  • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
  • store between 20 to 25°C (68 to 77°F)
Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Principal Display Panel

MAJOR®

NDC 0904-6986-40

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

MUCUS RELIEF 

Guaifenesin Extended-Release Tablets, 600 mg

EXPECTORANT

12 HOUR

Relieves Chest Congestion

Thins and Loosens Mucus

500 EXTENDED-RELEASE TABLETS

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.
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)
Package Label.principal Display Panel

Active Ingredient(in Each Extended Release Tablet)

Guaifenesin 600 mg


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

Warning (WARNING)

.

Directions (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: 1 or 2 tablets every 12 hours.  
  • Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use
Do Not Use (DO NOT USE)

for children under 12 years of age

Questions? (QUESTIONS?)

1-800-616-2471

You may also report side effects to this phone number. 

Other Information (OTHER INFORMATION)
  • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
  • store between 20 to 25°C (68 to 77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAJOR®

NDC 0904-6986-40

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

MUCUS RELIEF 

Guaifenesin Extended-Release Tablets, 600 mg

EXPECTORANT

12 HOUR

Relieves Chest Congestion

Thins and Loosens Mucus

500 EXTENDED-RELEASE TABLETS

Stop Use and Ask A Doctor If (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.
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)
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Active Ingredient(in Each Extended Release Tablet) (ACTIVE INGREDIENT(in each extended-release tablet))

Guaifenesin 600 mg


Advanced Ingredient Data


Raw Label Data

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