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Mucus Relief
Guaifenesin · Tablet, Extended Release
Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
Mucus Relief
Generic name
Guaifenesin
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Strategic Sourcing Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
43
Packages
59
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
102
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Respiratory Secretion Viscosity [PE] | PE | All 52 members |
| Expectorant [EPC] | EPC | All 48 members |
| Increased Respiratory Secretions [PE] | PE | All 48 members |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
213420
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 8, 2020
Sponsor
GRANULES
Products on application
2
Submissions recorded
2
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 213420-001 | GUAIFENESIN | TABLET, EXTENDED RELEASE | GUAIFENESIN | Over-the-counter | — | ||
| 213420-002 | GUAIFENESIN | TABLET, EXTENDED RELEASE | GUAIFENESIN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 1 | Labeling | Approved | December 9, 2022 | Standard |
| Original application | 1 | Approved | May 8, 2020 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260501). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260501 HUMAN OTC DRUG · 20260314 HUMAN OTC DRUG · 20251222 HUMAN PRESCRIPTION DRUG · 20250602
Indications and Usage
openFDA Drug LabelingUses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
Purpose
openFDA Drug LabelingPurpose Expectorant
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 the timing of meals adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use
Warnings
openFDA Drug LabelingWarnings Do not use • for children under 12 years of age 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. KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) right away.
Do Not Use
openFDA Drug LabelingDo not use ■ for children under 12 years of age
Ask a Doctor
openFDA Drug LabelingAsk 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
openFDA Drug LabelingStop 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.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each extended-release bi-layer tablet) Guaifenesin 1200 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Guaifenesin 600 mg: color white, shape capsule and the imprint code is G233. NDC: 71335-2642-1: 30 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-2: 20 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-3: 60 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-4: 40 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-5: 14 EXTENDED RELEASE TABLETs in a BOTTLE NDC: 71335-2642-6: 6 EXTENDED RELEASE TABLETs in a BOTTLE Store between 20 to 25°C (68 to 77°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERS202,963
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed 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 |
|---|---|---|---|---|
| 57344-203-02 | 57344-203 | AAA Pharmaceutical, Inc. | 2 BLISTER PACK in 1 CARTON (57344-203-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 1, 2024 |
| 61504-204-02 | 61504-204 | AMERIFOODS TRADING COMPANY | 1 BLISTER PACK in 1 CARTON (61504-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 20, 2025 |
| 80513-403-20 | 80513-403 | Advanced Rx LLC | 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (80513-403-20) | August 29, 2024 |
| 69168-459-02 | 69168-459 | Allegiant Health | 150 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-459-02) | April 24, 2024 |
| 69168-459-17 | 69168-459 | Allegiant Health | 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-459-17) | March 7, 2025 |
| 69168-459-75 | 69168-459 | Allegiant Health | 75 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-459-75) | April 24, 2024 |
| 69168-460-32 | 69168-460 | Allegiant Health | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-460-32) | April 23, 2024 |
| 69168-460-50 | 69168-460 | Allegiant Health | 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-460-50) | April 23, 2024 |
| 69168-460-98 | 69168-460 | Allegiant Health | 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-460-98) | March 7, 2025 |
| 71610-499-12 | 71610-499 | Aphena Pharma Solutions - Tennessee, LLC | 12 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-12) | April 16, 2021 |
| 71610-499-53 | 71610-499 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-499-53) | November 20, 2020 |
| 68391-724-95 | 68391-724 | BJWC (Berkley & Jensen / BJ's) | 1 BOTTLE in 1 CARTON (68391-724-95) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 20, 2025 |
| 37835-412-28 | 37835-412 | Bi-Mart | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (37835-412-28) | April 1, 2025 |
| 71335-2642-1 | 71335-2642 | Bryant Ranch Prepack | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2642-1) | June 2, 2025 |
| 71335-2642-2 | 71335-2642 | Bryant Ranch Prepack | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2642-2) | June 2, 2025 |
| 71335-2642-3 | 71335-2642 | Bryant Ranch Prepack | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2642-3) | June 2, 2025 |
| 71335-2642-4 | 71335-2642 | Bryant Ranch Prepack | 40 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2642-4) | June 2, 2025 |
| 71335-2642-5 | 71335-2642 | Bryant Ranch Prepack | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2642-5) | June 2, 2025 |
| 71335-2642-6 | 71335-2642 | Bryant Ranch Prepack | 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2642-6) | June 2, 2025 |
| 83324-096-14 | 83324-096 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BLISTER PACK in 1 CARTON (83324-096-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 7, 2024 |
| 83324-097-20 | 83324-097 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1 BLISTER PACK in 1 CARTON (83324-097-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 18, 2024 |
| 51316-724-94 | 51316-724 | CVS Pharmacy | 2 BLISTER PACK in 1 CARTON (51316-724-94) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 26, 2025 |
| 53942-203-02 | 53942-203 | Demoulas Super Markets, Inc | 1 BLISTER PACK in 1 CARTON (53942-203-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 1, 2022 |
| 53942-204-02 | 53942-204 | Demoulas Super Markets, Inc | 1 BLISTER PACK in 1 CARTON (53942-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 1, 2022 |
| 53943-233-32 | 53943-233 | Discount Drug Mart, Inc | 2 BLISTER PACK in 1 CARTON (53943-233-32) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 13, 2025 |
| 81522-203-02 | 81522-203 | FSA STORE INC. | 1 BLISTER PACK in 1 CARTON (81522-203-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 11, 2023 |
| 81522-204-02 | 81522-204 | FSA STORE INC. | 2 BLISTER PACK in 1 PACKAGE (81522-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 2, 2023 |
| 55319-551-07 | 55319-551 | Family Dollar (FAMILY WELLNESS) | 7 BLISTER PACK in 1 CARTON (55319-551-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2023 |
| 55319-733-14 | 55319-733 | Family Dollar (FAMILY WELLNESS) | 14 BLISTER PACK in 1 CARTON (55319-733-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 1, 2025 |
| 85828-723-02 | 85828-723 | Grocery Outlet, Inc. | 1 BLISTER PACK in 1 CARTON (85828-723-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 13, 2026 |
| 37808-830-20 | 37808-830 | H E B | 1 BOTTLE, PLASTIC in 1 BOX (37808-830-20) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | June 5, 2023 |
| 72036-203-02 | 72036-203 | HARRIS TEETER | 1 BLISTER PACK in 1 CARTON (72036-203-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2024 |
| 72036-204-02 | 72036-204 | HARRIS TEETER | 1 BLISTER PACK in 1 CARTON (72036-204-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2024 |
| 42507-253-03 | 42507-253 | HYVEE INC | 2 BLISTER PACK in 1 CARTON (42507-253-03) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 13, 2026 |
| 69256-731-20 | 69256-731 | Harris Teeter, LLC | 20 BLISTER PACK in 1 CARTON (69256-731-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 6, 2023 |
| 41226-723-02 | 41226-723 | KROGER COMPANY | 1 BLISTER PACK in 1 CARTON (41226-723-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 21, 2024 |
| 70000-0730-1 | 70000-0730 | LEADER/ Cardinal Health 110, Inc. | 2 BLISTER PACK in 1 CARTON (70000-0730-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 8, 2025 |
| 0904-6986-40 | 0904-6986 | Major Pharmaceuticals | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6986-40) | September 23, 2019 |
| 63739-067-02 | 63739-067 | McKesson Corporation dba SKY Packaging | 30 BLISTER PACK in 1 BOX (63739-067-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 20, 2021 |
| 79481-1204-1 | 79481-1204 | Meijer | 1 BLISTER PACK in 1 CARTON (79481-1204-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 14, 2025 |
| 79481-1204-2 | 79481-1204 | Meijer | 3 BLISTER PACK in 1 CARTON (79481-1204-2) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 14, 2025 |
| 0615-8637-39 | 0615-8637 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8637-39) | May 21, 2026 |
| 84324-026-01 | 84324-026 | NUVICARE LLC | 40 TABLET, EXTENDED RELEASE in 1 BOTTLE (84324-026-01) | December 16, 2025 |
| 84324-034-01 | 84324-034 | NUVICARE LLC | 24 TABLET, EXTENDED RELEASE in 1 BOTTLE (84324-034-01) | December 4, 2025 |
| 59726-237-07 | 59726-237 | P & L Development, LLC | 7 BLISTER PACK in 1 CARTON (59726-237-07) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 15, 2025 |
| 59726-237-14 | 59726-237 | P & L Development, LLC | 14 BLISTER PACK in 1 CARTON (59726-237-14) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 15, 2025 |
| 59726-734-20 | 59726-734 | P & L Development, LLC | 20 BLISTER PACK in 1 CARTON (59726-734-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 6, 2024 |
| 72090-011-01 | 72090-011 | Pioneer Life Sciences, LLC | 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-011-01) | December 22, 2025 |
| 72090-011-02 | 72090-011 | Pioneer Life Sciences, LLC | 100 TABLET, EXTENDED RELEASE in 1 PACKAGE (72090-011-02) | December 22, 2025 |
| 72090-012-01 | 72090-012 | Pioneer Life Sciences, LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-012-01) | December 4, 2025 |
| 72090-012-02 | 72090-012 | Pioneer Life Sciences, LLC | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-012-02) | December 4, 2025 |
| 72090-012-03 | 72090-012 | Pioneer Life Sciences, LLC | 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (72090-012-03) | December 4, 2025 |
| 0536-1392-88 | 0536-1392 | Rugby Laboratories | 14 BLISTER PACK in 1 CARTON (0536-1392-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0536-1392-46) | July 1, 2023 |
| 70677-1051-1 | 70677-1051 | Strategic Sourcing Services LLC | 14 BLISTER PACK in 1 CARTON (70677-1051-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 1, 2023 |
| 70677-1052-1 | 70677-1052 | Strategic Sourcing Services LLC | 20 BLISTER PACK in 1 CARTON (70677-1052-1) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 31, 2023 |
| 67091-403-02 | 67091-403 | WINCO FOODS, LLC | 2 BLISTER PACK in 1 CARTON (67091-403-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 11, 2023 |
| 67091-404-02 | 67091-404 | WINCO FOODS, LLC | 2 BLISTER PACK in 1 CARTON (67091-404-02) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 11, 2023 |
| 73581-403-01 | 73581-403 | YYBA Corp | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (73581-403-01) | July 1, 2026 |
| 73581-403-03 | 73581-403 | YYBA Corp | 35 TABLET, EXTENDED RELEASE in 1 BOTTLE (73581-403-03) | July 1, 2026 |
| 57344-203 | 57344-203 | AAA Pharmaceutical, Inc. | — | February 1, 2024 |
| 61504-204 | 61504-204 | AMERIFOODS TRADING COMPANY | — | November 20, 2025 |
| 80513-403 | 80513-403 | Advanced Rx LLC | — | May 8, 2020 |
| 69168-459 | 69168-459 | Allegiant Health | — | April 24, 2024 |
| 69168-460 | 69168-460 | Allegiant Health | — | April 23, 2024 |
| 71610-499 | 71610-499 | Aphena Pharma Solutions - Tennessee, LLC | — | September 23, 2019 |
| 68391-724 | 68391-724 | BJWC (Berkley & Jensen / BJ's) | — | August 20, 2025 |
| 37835-412 | 37835-412 | Bi-Mart | — | December 18, 2020 |
| 71335-2642 | 71335-2642 | Bryant Ranch Prepack | — | September 23, 2019 |
| 83324-096 | 83324-096 | CHAIN DRUG MARKETING ASSOCIATION, INC. | — | August 7, 2024 |
| 83324-097 | 83324-097 | CHAIN DRUG MARKETING ASSOCIATION, INC. | — | July 18, 2024 |
| 51316-724 | 51316-724 | CVS Pharmacy | — | May 26, 2025 |
| 53942-203 | 53942-203 | Demoulas Super Markets, Inc | — | October 1, 2022 |
| 53942-204 | 53942-204 | Demoulas Super Markets, Inc | — | October 1, 2022 |
| 53943-233 | 53943-233 | Discount Drug Mart, Inc | — | February 13, 2025 |
| 81522-203 | 81522-203 | FSA STORE INC. | — | January 11, 2023 |
| 81522-204 | 81522-204 | FSA STORE INC. | — | May 2, 2023 |
| 55319-551 | 55319-551 | Family Dollar (FAMILY WELLNESS) | — | July 1, 2023 |
| 55319-733 | 55319-733 | Family Dollar (FAMILY WELLNESS) | — | April 1, 2025 |
| 85828-723 | 85828-723 | Grocery Outlet, Inc. | — | March 13, 2026 |
| 37808-830 | 37808-830 | H E B | — | June 5, 2023 |
| 72036-203 | 72036-203 | HARRIS TEETER | — | March 1, 2024 |
| 72036-204 | 72036-204 | HARRIS TEETER | — | March 1, 2024 |
| 42507-253 | 42507-253 | HYVEE INC | — | January 13, 2026 |
| 69256-731 | 69256-731 | Harris Teeter, LLC | — | February 6, 2023 |
| 41226-723 | 41226-723 | KROGER COMPANY | — | May 21, 2024 |
| 70000-0730 | 70000-0730 | LEADER/ Cardinal Health 110, Inc. | — | April 8, 2025 |
| 0904-6986 | 0904-6986 | Major Pharmaceuticals | — | September 23, 2019 |
| 63739-067 | 63739-067 | McKesson Corporation dba SKY Packaging | — | October 20, 2021 |
| 79481-1204 | 79481-1204 | Meijer | — | March 14, 2025 |
| 0615-8637 | 0615-8637 | NCS HealthCare of KY, LLC dba Vangard Labs | — | September 23, 2019 |
| 84324-026 | 84324-026 | NUVICARE LLC | — | December 16, 2025 |
| 84324-034 | 84324-034 | NUVICARE LLC | — | December 4, 2025 |
| 59726-237 | 59726-237 | P & L Development, LLC | — | February 15, 2025 |
| 59726-734 | 59726-734 | P & L Development, LLC | — | December 6, 2024 |
| 72090-011 | 72090-011 | Pioneer Life Sciences, LLC | — | December 22, 2025 |
| 72090-012 | 72090-012 | Pioneer Life Sciences, LLC | — | December 4, 2025 |
| 0536-1392 | 0536-1392 | Rugby Laboratories | — | July 1, 2023 |
| 70677-1051 | 70677-1051 | Strategic Sourcing Services LLC | — | March 1, 2023 |
| 70677-1052 | 70677-1052 | Strategic Sourcing Services LLC | — | March 31, 2023 |
| 67091-403 | 67091-403 | WINCO FOODS, LLC | — | April 11, 2023 |
| 67091-404 | 67091-404 | WINCO FOODS, LLC | — | April 11, 2023 |
| 73581-403 | 73581-403 | YYBA Corp | — | July 1, 2026 |
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 · 11 sections on this page.