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Guaifenesin and Pseudoephedrine HCl
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Adrenergic alpha-Agonists [MoA] | MoA | All 85 members |
| Decreased Respiratory Secretion Viscosity [PE] | PE | All 52 members |
| Expectorant [EPC] | EPC | All 48 members |
| Increased Respiratory Secretions [PE] | PE | All 48 members |
| alpha-Adrenergic Agonist [EPC] | EPC | All 85 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 213203-001 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — | ||
| 213203-002 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | March 25, 2020 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251202). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure
Purpose
openFDA Drug LabelingActive ingredients (in each extended-release tablet) Purposes Guaifenesin 600 mg Expectorant Pseudoephedrine HCl 60 mg Nasal Decongestant Active ingredients (in each extended-release tablet) Purposes Guaifenesin 1200 mg Expectorant Pseudoephedrine HCl 120 mg Nasal Decongestant
Dosage and Administration
openFDA Drug LabelingDirections 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 For 600 mg/60 mg: adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 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 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)
Warnings
openFDA Drug LabelingWarnings Do not use 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 • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • 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 • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a 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 Centre right away (1-800 222-1222).
Other 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)
Do Not Use
openFDA Drug LabelingDo not use 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
openFDA Drug LabelingAsk a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.
Active Ingredient
openFDA Drug LabelingActive ingredient(s) Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: GUAIFENESIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 46122-801-08 | 46122-801 | Amerisource Bergen | 1 BLISTER PACK in 1 CARTON (46122-801-08) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 1, 2024 |
| 59651-287-22 | 59651-287 | Aurobindo Pharma Limited | 2000 TABLET, EXTENDED RELEASE in 1 BAG (59651-287-22) | March 25, 2020 |
| 59651-288-11 | 59651-288 | Aurobindo Pharma Limited | 1000 TABLET, EXTENDED RELEASE in 1 BAG (59651-288-11) | March 25, 2020 |
| 58602-833-12 | 58602-833 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-833-12) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 25, 2020 |
| 58602-833-17 | 58602-833 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-833-17) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 25, 2020 |
| 58602-834-77 | 58602-834 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-834-77) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 25, 2020 |
| 58602-834-78 | 58602-834 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-834-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 25, 2020 |
| 55111-798-77 | 55111-798 | Dr. Reddy's Laboratories Limited | 6 BLISTER PACK in 1 CARTON (55111-798-77) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-799-84 | 55111-799 | Dr. Reddy's Laboratories Limited | 5 BLISTER PACK in 1 CARTON (55111-799-84) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-798-09 | 55111-798 | Dr. Reddys Laboratories Limited | 1 BLISTER PACK in 1 CARTON (55111-798-09) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-798-18 | 55111-798 | Dr. Reddys Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-798-18) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-798-35 | 55111-798 | Dr. Reddys Laboratories Limited | 1 BLISTER PACK in 1 CARTON (55111-798-35) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 23, 2020 |
| 55111-798-36 | 55111-798 | Dr. Reddys Laboratories Limited | 4 BLISTER PACK in 1 CARTON (55111-798-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-798-41 | 55111-798 | Dr. Reddys Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-798-41) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 11, 2020 |
| 55111-799-04 | 55111-799 | Dr. Reddys Laboratories Limited | 4 BLISTER PACK in 1 CARTON (55111-799-04) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) | December 29, 2017 |
| 55111-799-12 | 55111-799 | Dr. Reddys Laboratories Limited | 1 BLISTER PACK in 1 CARTON (55111-799-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-799-24 | 55111-799 | Dr. Reddys Laboratories Limited | 2 BLISTER PACK in 1 CARTON (55111-799-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 55111-799-36 | 55111-799 | Dr. Reddys Laboratories Limited | 3 BLISTER PACK in 1 CARTON (55111-799-36) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 29, 2017 |
| 62207-827-72 | 62207-827 | Granules India Ltd | 9 BLISTER PACK in 1 CARTON (62207-827-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 1, 2023 |
| 62207-828-71 | 62207-828 | Granules India Ltd | 7 BLISTER PACK in 1 CARTON (62207-828-71) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 1, 2023 |
| 30142-137-12 | 30142-137 | KROGER COMPANY | 1 BLISTER PACK in 1 CARTON (30142-137-12) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 16, 2021 |
| 30142-137-17 | 30142-137 | KROGER COMPANY | 2 BLISTER PACK in 1 CARTON (30142-137-17) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 16, 2021 |
| 79481-1002-1 | 79481-1002 | Meijer | 1 BLISTER PACK in 1 CARTON (79481-1002-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 15, 2021 |
| 51660-074-18 | 51660-074 | Ohm Laboratories, Inc. | 1 BLISTER PACK in 1 CARTON (51660-074-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 1, 2021 |
| 51660-077-12 | 51660-077 | Ohm Laboratories, Inc. | 1 BLISTER PACK in 1 CARTON (51660-077-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 1, 2021 |
| 11822-0046-1 | 11822-0046 | Rite Aid Corporation | 1 BLISTER PACK in 1 CARTON (11822-0046-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 1, 2022 |
| 11822-0046-2 | 11822-0046 | Rite Aid Corporation | 2 BLISTER PACK in 1 CARTON (11822-0046-2) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 1, 2022 |
| 70677-1263-1 | 70677-1263 | Strategic Sourcing Services LLC | 1 BLISTER PACK in 1 CARTON (70677-1263-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 13, 2024 |
| 70677-1011-1 | 70677-1011 | Strategic Sourcing Services, LLC | 1 BLISTER PACK in 1 CARTON (70677-1011-1) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 5, 2023 |
| 0363-0134-78 | 0363-0134 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-0134-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 5, 2020 |
| 0363-9946-40 | 0363-9946 | WALGREEN CO. | 1 BLISTER PACK in 1 CARTON (0363-9946-40) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 7, 2022 |
| 0363-9946-45 | 0363-9946 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-9946-45) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 7, 2022 |
| 46122-801 | 46122-801 | Amerisource Bergen | — | October 1, 2024 |
| 59651-287 | 59651-287 | Aurobindo Pharma Limited | — | March 25, 2020 |
| 59651-288 | 59651-288 | Aurobindo Pharma Limited | — | March 25, 2020 |
| 58602-833 | 58602-833 | Aurohealth LLC | — | March 25, 2020 |
| 58602-834 | 58602-834 | Aurohealth LLC | — | March 25, 2020 |
| 55111-798 | 55111-798 | Dr. Reddy's Laboratories Limited | — | December 29, 2017 |
| 55111-799 | 55111-799 | Dr. Reddys Laboratories Limited | — | December 29, 2017 |
| 62207-827 | 62207-827 | Granules India Ltd | — | June 1, 2023 |
| 62207-828 | 62207-828 | Granules India Ltd | — | June 1, 2023 |
| 30142-137 | 30142-137 | KROGER COMPANY | — | April 16, 2021 |
| 79481-1002 | 79481-1002 | Meijer | — | July 15, 2021 |
| 51660-074 | 51660-074 | Ohm Laboratories, Inc. | — | April 1, 2021 |
| 51660-077 | 51660-077 | Ohm Laboratories, Inc. | — | April 1, 2021 |
| 11822-0046 | 11822-0046 | Rite Aid Corporation | — | February 1, 2022 |
| 70677-1263 | 70677-1263 | Strategic Sourcing Services LLC | — | December 13, 2024 |
| 70677-1011 | 70677-1011 | Strategic Sourcing Services, LLC | — | July 27, 2020 |
| 0363-0134 | 0363-0134 | WALGREEN CO. | — | August 5, 2020 |
| 0363-9946 | 0363-9946 | WALGREEN CO. | — | May 7, 2022 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.