bf32f7e3-2973-434a-a3c5-7e40bedf5f2a

SPL v1
SPL
SPL Set ID bf32f7e3-2973-434a-a3c5-7e40bedf5f2a
Route
oral
Published
Effective Date 2012-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (200 mg)
Inactive Ingredients
magnesium stearate maltodextrin cellulose, microcrystalline povidone stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;588 Shape: round Color: pink Size: 10 mm Score: 1
Marketing Status
otc monograph final active Since 2008-01-07
Purpose

Expectorant

Description

Guaifenesin 200 mg

Medication Information

Purpose
Expectorant
Directions
  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
adults and children 12 years 

of age and over		 1 to 2 tablets every

4 hours
children 6 to under 12 years

of age 

½ to 1 tablet every

4 hours 
children under 6 years of age  consult a physician 


Other Information
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • use by expiration date on package
Inactive Ingredients
FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid
Description

Guaifenesin 200 mg

Principal Display Panel
The product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.

NDC 54868-5847-0





 GUAIFENESIN TABLETS

Guaifenesin 200 mg

Expectorant
  • Relieves Chest Congestion
  • Thins and Loosens Mucus
100 Tablets Immediate Release



50844     REV0510A58812



 Distributed by MAJOR PHARMACEUTICALS

31788 Enterprise Drive,

Livonia, MI 48150 USA

Re-Order No. 238163        M-17         Rev. 11/10

 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146

Questions?
To Report Adverse Drug Event Call: (800) 616-2471
Use(s)
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
If Pregnant Or Breast Feeding,
ask a health professional before use.
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
  • 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 Immediate Release Tablet)
Guaifenesin 200 mg

Structured Label Content

Purpose
Expectorant
Directions
  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
adults and children 12 years 

of age and over		 1 to 2 tablets every

4 hours
children 6 to under 12 years

of age 

½ to 1 tablet every

4 hours 
children under 6 years of age  consult a physician 


Other Information (Other information)
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)
FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid
Principal Display Panel
The product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.

NDC 54868-5847-0





 GUAIFENESIN TABLETS

Guaifenesin 200 mg

Expectorant
  • Relieves Chest Congestion
  • Thins and Loosens Mucus
100 Tablets Immediate Release



50844     REV0510A58812



 Distributed by MAJOR PHARMACEUTICALS

31788 Enterprise Drive,

Livonia, MI 48150 USA

Re-Order No. 238163        M-17         Rev. 11/10

 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING





Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146

Questions?
To Report Adverse Drug Event Call: (800) 616-2471
Use(s)
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
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)
  • 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 Immediate Release Tablet) (Active ingredient (in each immediate-release tablet))
Guaifenesin 200 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:25.107459 · Updated: 2026-03-14T22:53:00.263233