TUSSLIN- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

TUSSLIN by

Drug Labeling and Warnings

TUSSLIN by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 5 mL 1 teaspoonful)

Dextromethorphan HBr 20 mg
Guaifenesin 388 mg
Phenylephrine HCl 10 mg

Purpose

Cough suppressant
Expectorant
Nasal decongestant

Uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
 temporarily relieves nasal congestion due to a cold

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  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.

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 for 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 6 doses in any 24-hour period
mL = milliliter, tsp = teaspoon

• adults and children 12 yearsof age and over: 5 mL (1 teaspoon); every 4 hours
• children under 12 yearsof age: do not use

Other information

 tamper evident feature: do not use if printed security seal is torn, broken or missing.
store at controlled room temperature 15-30ºC (59-86ºF)  avoid excessive heat or humidity.

Inactive ingredients

citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium citrate, sucralose

Questions or comments?

1-787-767-2072
You may also report serious side effects to this phone number.
Call weekdays from 8:00 am to 4:00 pm AST

SPL UNCLASSIFIED SECTION

Sugar, Alcohol, and Dye FREE

Manufactured for Kramer Novis,
San Juan, PR 00917

www.kramernovis.com

Made in USA with imported ingredients

Packaging

INGREDIENTS AND APPEARANCE

TUSSLIN 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-624
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-624-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/03/2025

Labeler - Kramer Novis (090158395)