mucus er

Manufacturer
H E B
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:55:38

Label at a glance#

Productmucus er
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 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 ° -25 ° C (68 ° -77 ° F) • do not use if printed foil under cap is broken or missing.

Label contents#

Full prescribing information#

Active ingredient (in each extended-release 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

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 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°-25°C (68°-77°F)
  • do not use if printed foil under cap is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Maximum Strength Mucinex® active ingredient

Maximum Strength

Mucus ER

Guaifenesin Extended-Release Tablets, 1200 mg

Expectorant

Relieves Chest Congestion

12 Hours

Thins and Loosens Mucus

actual size

14 EXTENDED-RELEASE TABLETS

3251J-mucus-ER.jpg
3251J-mucus-ER.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-32537808-325-66

Ingredients#

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

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

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091009-002GUAIFENESINGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0384e616aacf4f…
2026-08-18 06:07:402026-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033f01610625f2…
2019-09-15 20:21 UTC2019-09A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091009-002GUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORAL2015-09-03f41ea6bd6efb…

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
5986d3c3-7189-4808-84b3-8fb188c7b03bfdeb8e6a-2e89-41e7-8ccb-bc5f4e46fb1a2020-12-17WarningsExact identifier
spl set id: fdeb8e6a-2e89-41e7-8ccb-bc5f4e46fb1a

Reported adverse events (FAERS/openFDA)#

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