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Mucus Relief by HealthLife of USA LLC

Medically reviewed on June 5, 2017

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg
Labeler: HealthLife of USA LLC
NDC Code: 69517-119

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

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

Warnings

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 excessive phlegm (mucus)

When using this product
  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if
  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

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.

Directions:
  • adults and children 12 years of age and over: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years: do not use

Other information
  • each tablet contains: sodium 1.24 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to heat
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN Guai-Aid® 400*

Guaifenesin 400 mg

Expectorant

* This product is not manufactured or distributed by Health Products Express, Inc., owner of the registered trademark Guai-Aid® 400.

MUCUS RELIEF 
guaifenesin 400 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-119
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint CodeEB
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-119-2525 POUCH in 1 CARTON
12 TABLET in 1 POUCH
2NDC:69517-119-5050 POUCH in 1 CARTON
22 TABLET in 1 POUCH
3NDC:69517-119-022 POUCH in 1 POUCH
32 TABLET in 1 POUCH
4NDC:69517-119-101000 BOTTLE in 1 BOTTLE
4NDC:69517-119-05500 BOTTLE in 1 BOTTLE
4NDC:69517-119-1212 CARTON in 1 BOTTLE
41 TABLET in 1 CARTON
5NDC:69517-119-161 BOTTLE in 1 CARTON
516 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/13/2016
Labeler - HealthLife of USA LLC (079656178)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceutical Ltd.915664486manufacture(69517-119)

 
HealthLife of USA LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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