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Guaifenesin by REMEDYREPACK INC.

Medically reviewed on August 1, 2017

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: REMEDYREPACK INC.
NDC Code: 49349-511

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.

Major 44-588

Active ingredient (in each immediate-release tablet)

Guaifenesin 200 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
  • 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.

Directions
  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
adults and children 12 years
of age and over
1 to 2 tablets every
4 hours
children 6 to under 12 years
of age

½ to 1 tablet every
4 hours

children under 6 years of ageconsult a physician

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Questions or comments?

(800) 616-2471

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-511-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;588

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • GUAIFENESIN 200mg in 1

INACTIVE INGREDIENT(S):

  • FD&C RED NO. 40
  • MAGNESIUM STEARATE
  • STEARIC ACID
  • POVIDONE
  • CELLULOSE, MICROCRYSTALLINE
  • MALTODEXTRIN
  • SILICON DIOXIDE

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49349-511(NDC:0904-5154)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
FD&C RED NO. 40 
SILICON DIOXIDE 
Product Characteristics
Colorpink (dark) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;588
Contains    
Packaging
#Item CodePackage Description
1NDC:49349-511-0230 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/12/2010
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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