GUAIFENESIN- guaifenesin tablet 
Reliable 1 Laboratories 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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Guifenisen 400 mg

Drug Facts

Active ingredient (in each caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by 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

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

Drug Facts continued on back of label

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

Distributed by: Reliable-1 Laboratoreis LLC

Valley Stream, Ny 11580 www.reliable1labs.com

NDC 69618-061-06

Reliable-1 Laboratories

Guaifenesin 400 mg

Expectorant

60 CAPLETS

pdp

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code A;152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-061-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2020
Labeler - Reliable 1 Laboratories LLC (079718111)

Revised: 1/2021
Document Id: ae469d4f-91c5-cff0-e053-2995a90a0497
Set id: ae469d4f-91c4-cff0-e053-2995a90a0497
Version: 1
Effective Time: 20210101
 
Reliable 1 Laboratories LLC