Pseudoephedrine HCl and Guaifenesin

Manufacturer
Xspire Pharma, Llc
Effective date
2021-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:54:08

Label at a glance#

ProductPseudoephedrine HCl and Guaifenesin
Active ingredientGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive         ■ temporarily relieves nasal congestion due to:    ■ common cold    ■ hay fever    ■ upper respiratory allergies (allergic rhinitis) ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congest...

Dosage and administration

■ Do not exceed 4 doses in a 24 hour period ■ Adults and children 12 years of age and over : 1 tablet every 4 hours. ■ Children 6 to under 12 years of age : 1/2 tablet every 4 hours.

Storage and handling

■ store at 20°- 25°C (68°- 77°F) ■ tamper evident: do not use if foil seal under the cap is broken or missing. ■ contains 4 mg sodium in each tablet ■ contains less than 1 mg magnesium in each tablet

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Guaifenesin, USP 375 mg
Pseudoephedrine HCl, USP 60 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive        
■ temporarily relieves nasal congestion due to:
   ■ common cold
   ■ hay fever
   ■ upper respiratory allergies (allergic rhinitis)
■ temporarily restores freer breathing through the nose
■ promotes nasal and/or sinus drainage
■ temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

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 excessive phlegm (mucus)

When using this product
do not exceed the recommended dosage

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.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Do not exceed 4 doses in a 24 hour period
■ Adults and children 12 years of age and over: 1 tablet every 4 hours.
■ Children 6 to under 12 years of age: 1/2 tablet every 4 hours.

Other information

STORAGE AND HANDLING SECTION

■ store at 20°- 25°C (68°- 77°F)
■ tamper evident: do not use if foil seal under the cap is broken or missing.
■ contains 4 mg sodium in each tablet
■ contains less than 1 mg magnesium in each tablet

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch.

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 4PM CST at 1-888-252-3901 or go to www.xspirerx.com
email: customerservice@xspirerx.com

SPL UNCLASSIFIED SECTION

Distributed by:

Xspire Pharma
Ridgeland, MS 39157

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42195-281-102021-02-02C16284748780-1ba0f9c33-337e-a910-e053-dadaa90a0b85Pseudoephedrine HCl and Guaifenesin
42195-281-102021-01-29C16284748780-1ba0f9c33-337e-a910-e053-dadaa90a0b85Pseudoephedrine HCl and Guaifenesin

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-281-10EA - Each42195-281c70dbd41-afbc-47c1-b74c-1b34eae96b5712019-12-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42195-28142195-281-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
58a8f225-a45c-4535-b25e-db475525ed15e77ee125-139f-411f-a18b-297c126838962023-01-02WarningsExact identifier
spl set id: e77ee125-139f-411f-a18b-297c12683896

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.