TUSSLIN- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride 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.

----------

TUSSLIN®

Drug Facts

Active Ingredients (in each 5 mL tsp)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

Uses

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 the enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

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 or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• Take every 6 hours, or as directed by a doctor.

Adults and children 12 years of age and olderTake one teaspoonful (5 mL). Do not exceed 4 teaspoonfuls in 24 hours
Children 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL). Do not exceed 2 teaspoonfuls in 24 hours
Children 2 to under 6 years of ageTake 1/4 teaspoonful (1.25 mL). Do not exceed 1 teaspoonful in 24 hours
Children under 2 years of ageConsult a doctor

Other information

Inactive ingredients

Citric acid, flavor, glycerin, methylparaben, propylparaben, polyethylene glycol, purified water, sodium citrate, and sucralose.

Questions or comments?

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072. San Juan, PR 00917
www.kramernovis.com

NDC 52083-622-16

Contains the same active ingredients as Giltuss®*

Sugar, Alcohol, and Dye FREE

GRAPE FLAVOR

Manufactured in the USA for 

Kramer Novis

*Giltuss® is a registered trademark of Gil Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Gil Pharmaceutical Corp.

Packaging

Tusln1

TUSSLIN 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-622
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLE (clear, purple) Score    
ShapeSize
FlavorGRAPE (artificial grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-622-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2014
Labeler - Kramer Novis (090158395)

Revised: 9/2019
Document Id: e1b525d6-5d7a-4ee3-8ba8-a8e813157b4f
Set id: 14a6e659-f97b-44c2-bcf7-5e017c7f4001
Version: 4
Effective Time: 20190916
 
Kramer Novis