MUCUS RELIEF- guaifenesin tablet 
SPIRIT PHARMACEUTICALS LLC

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.

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ASSURED™ EXPECTORANT MUCUS RELIEF

Drug Facts

Active ingredient (in each caplet)                           

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

Do not use

  • for children under 12 years of age

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)

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. 1-800-222-1222

Directions

Other information

Inactive ingredients

Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Questions or comments?

1-888-333-9792

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton

ASSURED

EXPECTORANT

MUCUS 

RELIEF

Thins &

Loosens

Mucus,

Relieves Chest Congestion

Actual Size

PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton
MUCUS RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0116
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)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code EB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0116-11 in 1 CARTON03/15/201801/12/2022
115 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/2018
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
ELYSIUM PHARMACEUTICALS LTD915664486manufacture(68210-0116)

Revised: 1/2023
Document Id: f28eadfc-4cce-52f4-e053-2a95a90a928e
Set id: daa57e73-7ebb-4ca7-972f-10856abd0b67
Version: 5
Effective Time: 20230118
 
SPIRIT PHARMACEUTICALS LLC