FDA.reportPublic FDA data

Maximum Strength Mucus Relief

Manufacturer
SAM'S WEST INC | TIME CAP LABORATORIES,INC | MARKSANS PHARMA LIMITED
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:05

Label at a glance#

ProductMaximum Strength Mucus Relief
Active ingredientGUAIFENESIN
Label structure10 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 extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

-

Active ingredient (in each extended-release tablet)

OTC - ACTIVE INGREDIENT SECTION

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

OTC - DO NOT USE 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-290-4008 9:00 AM-5:00 PM ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ifc-56sifc-56s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY2

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
68196-033-56Maximum Strength Mucus Relief14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE142
68196-033-56Maximum Strength Mucus Relief4 in 1 CARTONTABLET, EXTENDED RELEASE42

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68196-03368196-033-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
COPOVIDONE K25-31D9C330MD8BIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSE 102PNR0YF693YIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GUAIFENESIN495W7451VQACTIB

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
A217780-001GUAIFENESINGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21
A217780-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2184e616aacf4f…
2026-09-14 22:38:342026-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2184e616aacf4f…
2026-08-18 06:07:402026-07A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-216a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-211c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217780-001GUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORAL2023-08-21a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217780-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-21a72a2bbeb626…

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
Maximum Strength Mucus ReliefGUAIFENESINSAM'S WEST INC39282544-e1e8-8270-e063-6394a90a23fe2025-08-13WarningsExact identifier
ndc (package): 68196-033-56
ndc (product): 68196-033
ndc11 (package): 68196003356
spl id: 3c3db64c-3dad-c118-e063-6294a90adc1b
spl set id: 39282544-e1e8-8270-e063-6394a90a23fe

Reported adverse events (FAERS/openFDA)#

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