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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

GUAIFENESIN: 8,042 Adverse Event Reports & Safety Profile

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8,042
Total FAERS Reports
158 (2.0%)
Deaths Reported
371
Hospitalizations
8,042
As Primary/Secondary Suspect
57
Life-Threatening
24
Disabilities
Aug 21, 2023
FDA Approved
Ohm Laboratories, Inc.
Manufacturer
OTC
Status
Yes
Generic Available

Drug Class: Decreased Respiratory Secretion Viscosity [PE] · Route: ORAL · Manufacturer: Ohm Laboratories, Inc. · FDA Application: 021282 · HUMAN OTC DRUG · FDA Label: Available

First Report: 1940 · Latest Report: 20250815

What Are the Most Common GUAIFENESIN Side Effects?

#1 Most Reported
Drug ineffective
1,583 reports (19.7%)
#2 Most Reported
Incorrect drug administration duration
490 reports (6.1%)
#3 Most Reported
No adverse event
462 reports (5.7%)

All GUAIFENESIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 1,583 19.7% 8 71
Incorrect drug administration duration 490 6.1% 0 5
No adverse event 462 5.7% 0 1
Product use in unapproved indication 451 5.6% 5 6
Dizziness 423 5.3% 1 26
Accidental overdose 396 4.9% 3 2
Diarrhoea 359 4.5% 2 9
Nausea 344 4.3% 3 56
Headache 308 3.8% 4 46
Product use issue 290 3.6% 4 5
Incorrect product administration duration 282 3.5% 0 1
Insomnia 271 3.4% 1 14
Overdose 271 3.4% 9 23
Wrong technique in product usage process 263 3.3% 1 0
Drug effective for unapproved indication 246 3.1% 0 0
Somnolence 237 3.0% 3 40
Dyspnoea 225 2.8% 1 36
Off label use 213 2.7% 5 52
Vomiting 209 2.6% 5 25
Cough 205 2.6% 1 19

Who Reports GUAIFENESIN Side Effects? Age & Gender Data

Gender: 64.3% female, 35.7% male. Average age: 63.4 years. Most reports from: US. View detailed demographics →

Is GUAIFENESIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 1 0
2002 1 0 0
2003 3 0 0
2004 1 0 0
2005 4 0 1
2007 1 0 0
2008 1 0 0
2009 6 1 1
2010 7 2 0
2011 10 2 0
2012 7 1 0
2013 30 4 3
2014 210 8 17
2015 667 6 20
2016 703 2 20
2017 406 6 13
2018 336 2 24
2019 268 3 9
2020 208 9 11
2021 150 3 16
2022 235 3 15
2023 178 0 8
2024 182 3 6
2025 93 0 4

View full timeline →

What Is GUAIFENESIN Used For?

IndicationReports
Product used for unknown indication 4,414
Cough 747
Respiratory tract congestion 588
Productive cough 522
Nasopharyngitis 274
Chronic obstructive pulmonary disease 168
Nasal congestion 117
Secretion discharge 113
Sinusitis 86
Pulmonary congestion 82

GUAIFENESIN vs Alternatives: Which Is Safer?

GUAIFENESIN vs GUAIFENESIN\HYDROCODONE GUAIFENESIN vs GUAIFENESIN\PSEUDOEPHEDRINE GUAIFENESIN vs GUANFACINE GUAIFENESIN vs GUSELKUMAB GUAIFENESIN vs HAIR KERATIN AMINO ACIDS GOLD COMPLEX GUAIFENESIN vs HALDOL GUAIFENESIN vs HALOBETASOL GUAIFENESIN vs HALOPERIDOL GUAIFENESIN vs HALOPERIDOL DECANOATE GUAIFENESIN vs HECTOROL

Other Drugs in Same Class: Decreased Respiratory Secretion Viscosity [PE]

Official FDA Label for GUAIFENESIN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Directions Do not crush, chew, or break tablet. Take with a full glass of water. This product can be administered without regard for timing of meals. Adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. Childrens under 12 years of age: do not use.

Dosage & Administration

Directions Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. Age (yr) Dose (ml) adults and children 12 years and over 10 to 20 ml (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours children 2 years to under 6 years 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours children under 2 years consult a physician Other Information Each 5 ml contains: sodium 4 mg.

Each

10 ml contains: sodium 8 mg.

Each

15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN.

Guaifenesin Oral

Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16

FDA Boxed Warning

BLACK BOX WARNING

Caution: do not use if imprinted seal under cap is broken or missing.

Warnings

Warnings Do not exceed recommended dosage. Do not use this product 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. Do not take this product, unless directed by a doctor, if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Do not take this product for persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Active Ingredient

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

Inactive Ingredients

Inactive Ingredients: Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.