Mucus Relief

Mucus Relief
SPL v1
SPL
SPL Set ID c648e711-e944-4574-83b3-ccce8732384e
Route
ORAL
Published
Effective Date 2011-12-30
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

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

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

How Supplied

Guaifenesin 600 mg: color white, shape capsule and the imprint code is G233. NDC: 71335-2642-1: 30 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-2: 20 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-3: 60 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-4: 40 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-5: 14 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-6: 6 EXTENDED RELEASE TABLETs in a BOTTLE Store between 20 to 25°C (68 to 77°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Expectorant

How Supplied

Guaifenesin 600 mg: color white, shape capsule and the imprint code is G233.

NDC: 71335-2642-1: 30 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-2: 20 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-3: 60 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-4: 40 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-5: 14 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-6: 6 EXTENDED RELEASE TABLETs in a BOTTLE

Store between 20 to 25°C (68 to 77°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

Section 51945-4

Guaifenesin ER 600mg Tablet

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

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)
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

Section 51945-4 (51945-4)

Guaifenesin ER 600mg Tablet

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. 

How Supplied (HOW SUPPLIED)

Guaifenesin 600 mg: color white, shape capsule and the imprint code is G233.

NDC: 71335-2642-1: 30 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-2: 20 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-3: 60 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-4: 40 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-5: 14 EXTENDED RELEASE TABLETs in a BOTTLE

NDC: 71335-2642-6: 6 EXTENDED RELEASE TABLETs in a BOTTLE

Store between 20 to 25°C (68 to 77°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

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

Guaifenesin 600 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)