FDA.reportPublic FDA data

Drug Facts

Manufacturer
INNOVUS PHARMACEUTICALS, INC. | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2026-10-27
Label type
Human OTC Drug Label
Version
1
Source
daily-update
Hydrated at
2026-10-30 01:01:39

Label at a glance#

ProductGuaifenesin and Dextromethorphan HBr
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure14 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 temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

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 timing of meals adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant
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
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION


Do not use

  • for children under 12 years of age
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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)

When using this product

OTC - WHEN USING SECTION


  • do not use more than directed

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 timing of meals
  • adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 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° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION


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

Questions?

OTC - QUESTIONS SECTION

call 1-855-274-4122

Distributed By:
Innovus Pharmaceuticals, Inc.
5740 Kietzke Lane #300
Reno, Nevada 89511

www.crclehealth.com

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active
ingredients of Maximum
Strength Mucinex® DM*

NDC 57483-114-28

C˙rcle™

Maximum Strength
Mucus Relief DM
Dextromethorphan HBr 60 mg - Cough Suppressant
Guaifenesin 1200 mg - Expectorant
Extended-release Tablets

 RELIEVES COUGH &
 CHEST CONGESTION

 12
 Hour

  •  Controls cough
  •   Thins & loosens
    mucus

 28 (4 x 7) EXTENDED-RELEASE TABLETS

63
Actual Size


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose TabletsPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Blister Carton 28 (4 x 7) Unit-dose Tablets

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
57483-11457483-114-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
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 44.

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
A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17
A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17c2088c7a36db…
2026-10-15 13:18:302026-09A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17c2088c7a36db…
2026-09-14 22:38:342026-08A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1784e616aacf4f…
2026-09-14 22:38:342026-08A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1784e616aacf4f…
2026-08-18 06:07:402026-07A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206941-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2017-03-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206941-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2017-03-174b0b4de00fa7…

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 15 · 285 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Adult Mucus Plus chest congestionGUAIFENESINMEIJER DISTRIBUTION, INCf6a23be6-0313-4c23-afb7-576666b80e212026-10-05WarningsName fallback
generic name: GUAIFENESIN
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsName fallback
generic name: GUAIFENESIN
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsName fallback
generic name: GUAIFENESIN
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsName fallback
generic name: GUAIFENESIN
good sense mucus erGUAIFENESINL. Perrigo Companydef40c3f-29de-4efc-b1d3-4cb89183aaec2026-09-03WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsName fallback
generic name: GUAIFENESIN
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsName fallback
generic name: GUAIFENESIN
Curist Mucus Relief Maximum StrengthGUAIFENESINLittle Pharma, Inc.c7d1136c-a712-2ac5-e053-2995a90a4dd42026-08-24WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus chest congestionGUAIFENESINCVS PHARMACYbec04049-03b2-4465-9cf5-0ad2ef8014ef2026-08-19WarningsName fallback
generic name: GUAIFENESIN
CVS Adult Mucus plus Chest CongestionGUAIFENESINCVS PHARMACY3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a2026-08-19WarningsName fallback
generic name: GUAIFENESIN
Mucus ReliefGUAIFENESINP & L Development, LLC3c01a88f-35c8-4e43-9997-ebee7943820f2026-08-10WarningsName fallback
generic name: GUAIFENESIN
GuaifedGUAIFENESINAldama Pharmaceuticals, Inc38f37272-2084-a33b-e063-6294a90ac1502026-08-10WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief Extended Release Maximum StrengthGUAIFENESINCVS Pharmacy34314503-b253-4b44-96ff-a42fe2bb161f2026-07-22WarningsName fallback
generic name: GUAIFENESIN
Mucus Relief ERGUAIFENESINCardinal Health 107, LLCf7abc2ff-21bc-48b5-9989-c5ac84f5c9cd2026-07-21WarningsName fallback
generic name: GUAIFENESIN
mucus reliefGUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51194399-6ded-4142-8880-9e810e6283522026-07-13WarningsName fallback
generic name: GUAIFENESIN
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsName fallback
generic name: GUAIFENESIN
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsName fallback
generic name: GUAIFENESIN
GuaifenesinGUAIFENESINAurohealth LLC062e3d83-8495-4c8f-b1e6-5eb37fd532242026-07-03WarningsName fallback
generic name: GUAIFENESIN
equate mucus-erGUAIFENESINWALMART INC.a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea32026-07-02WarningsName fallback
generic name: GUAIFENESIN

Reported adverse events (FAERS/openFDA)#

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