GUAIFENESIN- guaifenesin tablet 
REMEDYREPACK INC.

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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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

  • cough accompanied by 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 persists more than 7 days, tends to recur, or is accompanied by a 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 (1-800-222-1222) right away.

Directions

  • do not exceed 6 doses in 24 hours
  • take with a full glass of water
adults and children 12 years and over1 to 2 tablets every 4 hours
children 6 to under 12
years

½ to 1 tablet every 4 hours
children under 6 years
ask a doctor

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, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

(800) 616-2471

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1782-0

COLOR: pink

SHAPE: ROUND

SCORE: Two even pieces

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
  • MALTODEXTRIN
  • MICROCRYSTALLINE CELLULOSE
  • POVIDONE
  • SILICON DIOXIDE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • STEARIC ACID

Remedy_Label

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1782(NDC:0904-5154)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colorpink (dark) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 44;588
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1782-030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/07/201910/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/07/201910/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 07d508bd-abf2-06ae-e063-6294a90a39b1
Set id: 6aee53c7-5033-4b63-a2f2-f5fcd9371869
Version: 5
Effective Time: 20231016
 
REMEDYREPACK INC.