Active Ingredients And Purpose
Active ingredients
( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg
Purposes
Cough suppressant Expectorant
GUAIFENESIN - TOPCO ASSOCIATES LLC | Aurohealth LLC | Aurobindo Pharma Limited
- Manufacturer
- TOPCO ASSOCIATES LLC | Aurohealth LLC | Aurobindo Pharma Limited
- Effective date
- 2026-04-23
- Label type
- Human OTC Drug Label
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:54:48
Key Label Information#
Uses
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
Warnings
Warnings
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
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
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,
ask a health professional before use.
Directions And Dosage
Directions
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 Label Information
Other information
store at 20° to 25°C (68° to 77°F)
Inactive ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)
Questions?
call 1-855-274-4122 DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO ARHA0825 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com MADE IN INDIA
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 60 mg/1200 mg Blister Carton 56 (8 x 7) Unit-Dose Tablets
TopCare ® health NDC 76162-032-56 COMPARE TO THE ACTIVE INGREDIENTS OF MAXIMUM STRENGTH MUCINEX ® DM* MAXIMUM STRENGTH Mucus DM DEXTROMETHORPHAN HBr and GUAIFENESIN EXTENDED-RELEASE TABLETS 60 mg/1200 mg DEXTROMRTHORPHAN HBr 60 mg - COUGH SUPPRESSANT GUAIFENESIN 1200 mg - EXPECTORANT RELIEVES COUGH & CHEST CONGESTION 12 HOUR • Controls Cough • Thins & Loosens Mucus FOR DAY OR NIGHT 56 EXTENDED-RELEASE TABLETS actual size
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1099074 | guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet | PSN | 2 |
| 1099074 | 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet | SCD | 2 |
| 1099074 | dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-032-56 | GUAIFENESIN AND DEXTROMETHORPHAN HBR | 7 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 7 | 2 | |
| 76162-032-56 | GUAIFENESIN AND DEXTROMETHORPHAN HBR | 8 in 1 CARTON | TABLET, EXTENDED RELEASE | 8 | 2 |
Products#
- GUAIFENESIN AND DEXTROMETHORPHAN HBR
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76162-032 | 76162-032-56 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE K90 | RDH86HJV5Z | IACT |
| POVIDONE K25 | K0KQV10C35 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
Complete SPL Sections#
Active ingredients
( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg
Purposes
Cough suppressant Expectorant
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
Warnings
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
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
do not use more than directed
Stop use and ask a doctor if
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,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
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
store at 20° to 25°C (68° to 77°F)
Inactive ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)
Questions?
call 1-855-274-4122 DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO ARHA0825 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com MADE IN INDIA
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 60 mg/1200 mg Blister Carton 56 (8 x 7) Unit-Dose Tablets
TopCare ® health NDC 76162-032-56 COMPARE TO THE ACTIVE INGREDIENTS OF MAXIMUM STRENGTH MUCINEX ® DM* MAXIMUM STRENGTH Mucus DM DEXTROMETHORPHAN HBr and GUAIFENESIN EXTENDED-RELEASE TABLETS 60 mg/1200 mg DEXTROMRTHORPHAN HBr 60 mg - COUGH SUPPRESSANT GUAIFENESIN 1200 mg - EXPECTORANT RELIEVES COUGH & CHEST CONGESTION 12 HOUR • Controls Cough • Thins & Loosens Mucus FOR DAY OR NIGHT 56 EXTENDED-RELEASE TABLETS actual size