MUCUS RELIEF- guaifenesin tablet, coated 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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 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 with 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 with fever, rash, or persistent headache. These could be signs of a serious condition.

if pregnant or breast-feeding

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children

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 older: 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 of age: do not use

Other information

  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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

Package/Label Principal Display Panel

Mucus Relief Packaging Label

NDC 63548-6352-*1

IMMEDIATE ACTING

MUCUS RELIEF

EXPECTORANT

400 mg Guaifenesin

Relieves Chest Congestion

Thins and Loosens Mucus

30 TABLETS

MUCUS RELIEF 
guaifenesin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-3733
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 POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize5mm
FlavorImprint Code G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-3733-130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/201002/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/02/201002/28/2017
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017
Document Id: 7305a55d-a068-4cee-959a-76dca6e9dc4b
Set id: 8ec52f26-6b58-4b66-8653-614cf055ba80
Version: 2
Effective Time: 20170331
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions