FDA.reportPublic FDA data

Guaifenesin

Manufacturer
RITE AID CORPORATION | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-12-01
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:11

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure13 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 crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Guaifenesin USP 1200 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


Do not use

  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION


  • 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

OTC - STOP USE SECTION


  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION


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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

Questions?

OTC - QUESTIONS SECTION

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.


DISTRIBUTED BY:RITE AID,
30 HUNTER LANE, CAMP HILL,
PA 17011   www.riteaid.com

MADE IN INDIA
Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active Ingredient in Maximum Strength Mucinex®*

NDC 11822-4260-1


MAXIMUM STRENGTH
MUCUS
RELIEF
GUAIFENESIN EXTENDED-RELEASE
TABLETS 1200 mg  
EXPECTORANT

Relieves chest congestion
Thins & loosens mucus

12
HOUR                  ACTUAL SIZE

14
EXTENDED-RELEASE
TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN3
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD3
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4260-1Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
11822-4260-1Guaifenesin1 in 1 CARTONTABLET, EXTENDED RELEASE13
11822-4260-2Guaifenesin2 in 1 CARTONTABLET, EXTENDED RELEASE23
11822-4260-2Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
11822-4260-3Guaifenesin3 in 1 CARTONTABLET, EXTENDED RELEASE33
11822-4260-3Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4260GUAIFENESIN TABLET, EXTENDED RELEASE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 6 package rows20231202_de16ec42-4a31-4b18-e053-2995a90a78a4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-426011822-4260-1, 11822-4260-2, 11822-4260-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT
HYPROMELLOSE 2910 (10000 MPA.S)0HO1H52958IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
POVIDONE K90RDH86HJV5ZIACT
POVIDONE K25K0KQV10C35IACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210453-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21
A210453-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2184e616aacf4f…
2026-09-14 22:38:342026-08A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2184e616aacf4f…
2026-08-18 06:07:402026-07A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210453-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2019-10-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210453-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2019-10-2174a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINRITE AID CORPORATIONde16ec42-4a31-4b18-e053-2995a90a78a42023-12-01WarningsExact identifier
ndc (package): 11822-4260-1
ndc (package): 11822-4260-3
ndc (package): 11822-4260-2
ndc (product): 11822-4260
ndc11 (package): 11822426001
ndc11 (package): 11822426003
ndc11 (package): 11822426002
spl id: afdc12f3-6003-4da4-a148-2c7350e3b178
spl set id: de16ec42-4a31-4b18-e053-2995a90a78a4

Reported adverse events (FAERS/openFDA)#

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