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Guaifenesin and Pseudoephedrine HCl

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
Guaifenesin and Pseudoephedrine HCl
Generic name
Guaifenesin and Pseudoephedrine HCl
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurobindo Pharma Limited
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
18
Packages
32
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Guaifenesin 1200 mg/1 359601 View
Guaifenesin 600 mg/1 359601 View
Pseudoephedrine Hydrochloride 120 mg/1 1305603 View
Pseudoephedrine Hydrochloride 60 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
50

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
213203
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 25, 2020
Sponsor
AUROBINDO PHARMA LTD
Products on application
2
Submissions recorded
1
Products approved under application 213203.
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
Most recent submissions on application 213203.
Type No. Action Status Date Review
Original application 1 Approved March 25, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced 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.

HUMAN OTC DRUG · 20251202 HUMAN OTC DRUG · 20251024 HUMAN OTC DRUG · 20241023

Indications and Usage

openFDA Drug Labeling

Use(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

Active 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 Labeling

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 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  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 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 Labeling

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)

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.

Active Ingredient

openFDA Drug Labeling

Active 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 FAERS
202,963
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.