MUCUS RELIEF IMMEDIATE RELEASE- guaifenesin tablet 
Allegiant Health

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

Guaifenesin 400mg

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,

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

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

  • 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
  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Inactive Ingredients

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

Package/Label Principal Display Panel

 Health A2Z®

Immediate release

MUCUS RELIEF

Guaifenesin 400mg

EXPECTORANT

• Relieves Chest Congestion
• Thins and Loosens Mucus

TABLETS

Guaifenesin 400mg

Guaifenesin 400mg

MUCUS RELIEF  IMMEDIATE RELEASE
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-330
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize17mm
FlavorImprint Code TCL272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-330-4115 in 1 CARTON; Type 0: Not a Combination Product12/23/201411/30/2021
2NDC:69168-330-3030 in 1 CARTON; Type 0: Not a Combination Product12/23/201411/30/2021
3NDC:69168-330-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/201411/30/2021
4NDC:69168-330-17300 in 1 BOTTLE; Type 0: Not a Combination Product12/23/201411/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/23/201411/30/2021
Labeler - Allegiant Health (079501930)

Revised: 11/2017
Document Id: c981f743-716a-4a6e-aae4-509f085afef0
Set id: 9f384bbe-077d-47da-866d-9b29d1bbe8d9
Version: 7
Effective Time: 20171113
 
Allegiant Health