MUCUS RELIEF EXPECTORANT- guaifenesin tablet 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

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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DRUG FACTS

Active Ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

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 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 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 (1800-222-1222).

Directions

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

Other information

  • each tablet contains: sodium 5 mg
  • store between 20-25ºC(68-77ºF)

Inactive ingredients

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

Questions or Comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

EXPECTORANT

Mucus Relief

• Guaifenesin 400 mg

Thins & loosens Mucus, Relieves Chest Congestion

tablets

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Product Label

Guaifenesin 400 mg

ASSURED Mucus Relief

MUCUS RELIEF  EXPECTORANT
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0107
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code TCL272;G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0107-11 in 1 BOX04/16/201304/16/2020
115 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/16/201304/16/2020
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Revised: 7/2019
Document Id: 7e6eec55-58d7-4b0d-be33-a6951e170868
Set id: 287ce9dd-d28d-48ff-a91c-8e33c968141e
Version: 5
Effective Time: 20190710
 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)