SUDOGEST- pseudoephedrine hydrochloride liquid 
Major Pharmaceuticals, Inc

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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SudoGest Children's Syrup

Drug Facts

Active Ingredient

Active ingredient (in each 5 mL) Purpose

Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant

Purpose

Nasal decongestant

Uses

•
temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
•
temporarily relieves sinus congestion and pressure
•
promotes nasal and/or sinus drainage

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
•
a sodium restricted diet

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 improve within 7 days or occur with fever

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

Keep Out of Reach of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

•
Take at every 6 hours, if needed
•
Do not exceed 4 doses in 24 hours.

Adults and children 12 years of age and over

4 teaspoonfuls (tsp)

Children 6 to under 12 years of age

2 teaspoonfuls (tsp)

Children under 6 years of age

DO NOT USE

Other information

store at room temperature

Inactive ingredients

citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, grape flavor, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

Questions? Serious Adverse Effects call:

800-616-2471

†Major SudoGest is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Sudafed® Nasal Decongestant.

Distributed by:

Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA

Carton Label
SUDOGEST 
pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5367
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine hydrochloride15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
saccharin sodium (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
sorbitol (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5367-20118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/200102/29/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/05/200102/29/2012
Labeler - Major Pharmaceuticals, Inc (191427277)
Registrant - Silarx Pharmaceuticals, Inc (161630033)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-5367)

Revised: 11/2017
Document Id: c936aeb3-a182-4fa7-9d6c-6bfa1ac94ab3
Set id: 0ae49d7e-ceec-4ad6-a0b8-cb20237e2b70
Version: 4
Effective Time: 20171113
 
Major Pharmaceuticals, Inc