RESPAIRE-30- guaifenesin capsule 
Laser Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient Section

Drug facts

Active ingredients (in each immediate-release capsule) Guaifensin 150 mg  Pseudoephedine HCL 30mg

Purpose Section

Purpose  Expectorant  Nasal decongestant

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.

Indications and Uses Section

Uses

helps to 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 :  the common cold  hay fever  upper respiratory allergies  temporarily restores free breathing through the nose  promotes nasal and /or sinus drainage  temporarily relieves sinus congestion and pressure

Warning Section

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  diabetes  high blood pressure   thyroid disease  trouble urinating due to 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 fever, rash or persistant headache. These could be signs of a serious illness.

Dosage and Administration Section

Directions

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 older  1 or 2 capsules every 4-6 hours: not more than 8 capsules in 24 hours

children 6 to under 12 years of age  1 capsule every 4-6 hours: not more than 4 capsules in 24 hours

children under 6 years of age  do not use

Inactive Ingredient Section

Inactive ingredients

corn starch, DandC yellow #10,FDandC blue #!, FDandC red #$), gelatin, iron oxide back, povidone, shellac, sugar, talc, titanium dioxide

Pregnancy or Breast-Feeding Section

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

Other Information Section

Other information

store at 25 degrees C (77 degrees) excursions permitted between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

use by expiration date on package

Questions Section

Questions? call 1-864-286-8229, 24 hours a day

Package Display Label

LASER NDC 16477-306-01  Respaire-30  Immediate-Release Capsules

Guaifensin 150 mg  Pseudoephedrine Hydrochloride 30 mg 

NASAL DECONGESTANT  EXPECTORANT  Clears Nasal/Sinus Congestion  Thins and Loosens Mucus

100 CAPSULES

TAMPER EVIDENT:  DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN, OR MISSING

Manufactured by: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735  308T  0309

Manufactured for Laser Pharmaceuticals, LLC Grenville, SC 29615  Lot #:      Exp. Date: 

  PEEL HERE FOR MORE DRUG FACTS  STOP PEELING


Respaire-30 Label

Respaire-30 Label 1


RESPAIRE-30 
guaifenesin capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-306
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN150 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorgreen (clear body with an opaque light green cap) Scoreno score
ShapeCAPSULE (Capsule) Size19mm
FlavorImprint Code LASER360
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-306-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/02/200811/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/02/200811/30/2019
Labeler - Laser Pharmaceuticals, LLC (614417132)
Registrant - Laser Pharmaceuticals, LLC (614417132)

Revised: 9/2019
 
Laser Pharmaceuticals, LLC