Guaifenesin by Reliable 1 Laboratories LLC Guifenisen 400 mg

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 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

• do not take more than 6 doses in any 24- hour period
• this product is not intended for use in children under 12 years of age
• adults & children 12 years and over: 1 caplet every 4 hours
• children under 12 years: do not use

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

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	A;152
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-061-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2020

Labeler - Reliable 1 Laboratories LLC (079718111)

Registrant - Reliable 1 Laboratories LLC (079718111)

Revised: 3/2023

Document Id: f810438c-ac8c-a572-e053-6394a90a363e

34390-5

Set id: ae469d4f-91c4-cff0-e053-2995a90a0497

Version: 3

Effective Time: 20230329