PSEUDOEPHEDRINE HCL AND GUAIFENESIN- pseudoephedrine hcl, guaifenesin tablet

Pseudoephedrine HCl and Guaifenesin by

Drug Labeling and Warnings

Pseudoephedrine HCl and Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Xspire Pharma, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each tablet)

Guaifenesin, USP 375 mg
Pseudoephedrine HCl, USP 60 mg

Purpose

Expectorant

Nasal Decongestant

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 congestion and pressure

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 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.

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

Directions

■ 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

■ 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

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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by:

Xspire Pharma
Ridgeland, MS 39157

Packaging

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HCL AND GUAIFENESIN 
pseudoephedrine hcl, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42195-281
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	375 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42195-281-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/24/2019

Labeler - Xspire Pharma, Llc (078312042)