Mucus Relief Guaifenesin 400 mg Caplets

Mucus Relief by

Drug Labeling and Warnings

Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MUCUS RELIEF- guaifenesin 400 mg tablet 
Safrel Pharmaceuticals, LLC

----------

Mucus Relief Guaifenesin 400 mg Caplets

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 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

Principal Display Panel

200 ct

200 ct300 ct

300 ct500 ct

500 ct

MUCUS RELIEF 
guaifenesin 400 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71309-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code G400
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71309-008-02200 in 1 BOTTLE; Type 0: Not a Combination Product07/01/202007/01/2020
2NDC: 71309-008-03300 in 1 BOTTLE; Type 0: Not a Combination Product04/13/201604/13/2016
3NDC: 71309-008-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/13/201604/13/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/13/201607/01/2020
Labeler - Safrel Pharmaceuticals, LLC (080566287)

Revised: 6/2025
Document Id: 38874088-70c7-6f5d-e063-6394a90a3940
Set id: b0c66e35-b348-4ff5-e053-2a95a90a5b57
Version: 5
Effective Time: 20250627