Label at a glance#

ProductGuaifenesin

Active ingredientGUAIFENESIN

Label structure9 sections

Indications and uses

Helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

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 and children 12 years and over 1 to 2 tablets every 4 hours Children under 12 years Do not use

Contacts and useful links#

PhoneLabel contact1 (855) 361-3993

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each immediate-release tablet)

Guaifenesin USP, 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

Helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS

WARNINGS SECTION

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 is accompanied by fever, rash or persistent headache. This could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 and children 12 years and over 1 to 2 tablets every 4 hours
Children under 12 years Do not use

Other Information

SPL UNCLASSIFIED SECTION

store at 15-30 °C (59-86 °F)
you may report serious side effects to: AvKARE, Inc. at 1 (855) 361-3993

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, FD&C red #40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-382-15
Guaifenesin Tablets USP
200mg
EXPECTORANT
For Ages 12 and Over
50 Tablets (5 x 10) Unit Dose
5026838215

Drug Facts

Active ingredient Purpose
(in each immediate-release tablet)
Guaifenesin USP, 200 mg ...................... Expectorant

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Drug Facts (continued)

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 last 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 and children 12 years and over 1 to 2 tablets every 4 hours

children under 12 years do not use

Drug Facts (continued)

Other information
• store at 15° to 30°C (59° to 86°F).
You may report serious side effects to: AvKARE, Inc. at 1 (855) 361-3993

Inactive ingredients
colloidal silicon dioxide, FD&C red #40 (Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid.

Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Mfg. Rev. 04/15 AV 09/16 (P)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15338-769-05	2020-01-31	C162847	48780-1	9d75b9d0-644b-f424-e053-dadaa90a57ce	Guaifenesin Tablets USP, 200 mg (Product contract packaged by Apace Packaging, LLC)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-4890-21	EA - Each	0603-4890	d7f27fdb-1aad-4f5d-87c4-56c426724c9a	1	2015-07-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15338-769	15338-769-11, 15338-769-05
0603-4890

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7b197f8e-6e14-7226-e053-2a91aa0ad2a9			7b197f8e-6e13-7226-e053-2a91aa0ad2a9	2018-11-20	Warnings	Exact identifier spl id: 7b197f8e-6e14-7226-e053-2a91aa0ad2a9 spl set id: 7b197f8e-6e13-7226-e053-2a91aa0ad2a9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

adults and children 12 years and over	1 to 2 tablets every 4 hours
Children under 12 years	Do not use