MUCUS RELIEF- guaifenesin tablet, film coated 
Better Living Brands, 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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Signature Care 44-532-delisted

Active ingredient (in each immediate-release tablet)

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

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus) 
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 

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.

Directions

  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 21130-955-12

Signature™
care

Mucus Relief
Guaifenesin 400 mg
Expectorant

Immediate-release
tablets

• Relieves chest congestion
• Thins and loosens mucus

Quality Guaranteed

Actual Size

100 TABLETS

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

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929     www.betterlivingbrandsLLC.com

50844     REV0812C53212

Signature Care 44-532

Signature Care 44-532

MUCUS RELIEF 
guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-955
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code 44;532
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-955-121 in 1 CARTON12/22/200507/30/2021
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/200507/30/2021
Labeler - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(21130-955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(21130-955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(21130-955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(21130-955)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(21130-955)

Revised: 7/2019
Document Id: 681439ae-3cd8-4c74-8061-44967fced2c7
Set id: 36d3665d-bae1-4864-b461-44d0facbbf3c
Version: 8
Effective Time: 20190720
 
Better Living Brands, LLC