FDA.reportPublic FDA data

Guaifenesin

Manufacturer
CVS PHARMACY, INC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:27:23

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 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

Label contents#

Full prescribing information#

Active ingredients (in each extended-release bi-layer tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 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

Do not use

WARNINGS SECTION

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 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

OTHER SAFETY INFORMATION

  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

Questions?

OTC - QUESTIONS SECTION

Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28ct28ct424214 count14 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN5
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD5
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY5

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
69842-335-16Guaifenesin14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE145
69842-335-28Guaifenesin28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE285
69842-335-42Guaifenesin42 in 1 BLISTER PACKTABLET, EXTENDED RELEASE425

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-33569842-335-16, 69842-335-28, 69842-335-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
GUAIFENESIN495W7451VQACTIB
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
A213420-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08
A213420-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0884e616aacf4f…
2026-09-14 22:38:342026-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0884e616aacf4f…
2026-08-18 06:07:402026-07A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213420-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2020-05-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213420-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2020-05-08bb7c543d1eb4…

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
GuaifenesinGUAIFENESINCVS PHARMACY, INCbdaf7359-8698-87d6-e053-2a95a90ada282025-12-19WarningsExact identifier
ndc (package): 69842-335-16
ndc (package): 69842-335-28
ndc (package): 69842-335-42
ndc (product): 69842-335
ndc11 (package): 69842033542
ndc11 (package): 69842033516
ndc11 (package): 69842033528
spl id: 4653e896-cfea-4625-e063-6394a90a4c7f
spl set id: bdaf7359-8698-87d6-e053-2a95a90ada28

Reported adverse events (FAERS/openFDA)#

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