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

HOW SUPPLIED

Guaifenesin 400 mg

NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC

Store at 15°-30°C (59°-86°F)

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Guaifenesin 400 mg Tablet

GUAIFENESIN
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-9616(NDC:69618-061)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-9616-1	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2024
2	NDC:71335-9616-2	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/28/2022
3	NDC:71335-9616-3	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2024
4	NDC:71335-9616-4	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2024
5	NDC:71335-9616-5	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/01/2020

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-9616) , RELABEL(71335-9616)

Guifenisen 400 mg