G TRON- guaifenesin dextromethorphan syrup 
Kramer Novis

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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Drug Facts

Active Ingredients (In Each 5ml (tsp))                       

Guaifenesein    100 mg

Dextromethorphan HBr. 10 mg

Uses: helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial

passages of bothersome mucus, drain bronchial tubes, and make coughs

more productive

restores free breathing

suppresses cough due to minor throat and bronchial irritation associated with a

cold or inhaled irritants

Directions

do not take more than 6 doses in any 24-hour period

Adults and Children 12 years of age and over 10 mL (2 tsp)

Children 6 to under 12 years of age 5 mL (1 tsp) E V E RY

4 HOURS

Children 2 to under 6 years of age 2.5 mL (½ tsp)

Children under 2 year of age Consult physician

Warnings:

Do not:

• use more than the recommended dose

• give this product to a child who has heart disease, high blood pressure, thyroid

disease, or diabetes unless directed by a doctor.

• 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.

• diabetes • heart disease • thyroid disease • high blood pressure • trouble

urinating due to an enlarged prostate gland • cough that occurs with too much

phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking,

asthma, chronic bronchitis or emphysema.

Ask a doctor before use if you have

When using this product do not use more than directed.

If pregnant or breast-feeding baby, 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.  

Prompt medical attention is critical for adults as well as for  

children even if you do not notice any signs or symptoms.

Enter section text here

Purpose: Expectorant, Cough Suppressant

G Tron 16 ozG Tron 16 oz

G TRON 
guaifenesin dextromethorphan syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHERRY (UNII: BUC5I9595W)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (sour cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-601-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/201211/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/18/201211/15/2018
Labeler - Kramer Novis (090158395)
Registrant - Ultraseal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(52083-601)

Revised: 11/2018
 
Kramer Novis