Organ-i Nr

Organ-i Nr
SPL v3
SPL
SPL Set ID cd31b4d5-1bea-472d-bfe8-00e3965c6330
Route
ORAL
Published
Effective Date 2017-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
D&c Red No. 30 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Starch, Corn Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 4740;V Shape: round Color: red Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2002-07-01

Description

Guaifenesin, USP 200 mg

Purpose

Expectorant

How Supplied

Product: 68151-1929 NDC: 68151-1929-2 1 TABLET in a PACKAGE


Medication Information

Purpose

Expectorant

How Supplied

Product: 68151-1929

NDC: 68151-1929-2 1 TABLET in a PACKAGE

Description

Guaifenesin, USP 200 mg

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA



Rev. 3/11 R5 8080143 4740

Section 50566-9

cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Stop use and ask a doctor if

Section 53414-9

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

Directions
  • do not take more than 6 doses in any 24-hour period  
  • this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over 

1 - 2 tablets every 4 hours 

children under 12 years 

do not use 
Active Ingredient

Guaifenesin, USP 200 mg

Other Information
  • store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients

D&C red #30 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinylpyrrolidine, pregelatinized starch, silicon dioxide, stearic acid

Guaifenesin 200 Mg Tab
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)  
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5 (42229-5)

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA



Rev. 3/11 R5 8080143 4740

Section 50566-9 (50566-9)

cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Stop use and ask a doctor if

Section 53414-9 (53414-9)

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

Purpose

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period  
  • this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over 

1 - 2 tablets every 4 hours 

children under 12 years 

do not use 
How Supplied (HOW SUPPLIED)

Product: 68151-1929

NDC: 68151-1929-2 1 TABLET in a PACKAGE

Active Ingredient (Active ingredient)

Guaifenesin, USP 200 mg

Other Information (Other information)
  • store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients (Inactive ingredients)

D&C red #30 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinylpyrrolidine, pregelatinized starch, silicon dioxide, stearic acid

Guaifenesin 200 Mg Tab (Guaifenesin 200 MG TAB)
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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)  
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)