TUSSLIN

Manufacturer
Kramer Novis
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:20:21

Label at a glance#

ProductTUSSLIN
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

• do not take more than 6 doses in any 24-hour period • mL = milliliter, tsp = teaspoon adults and children 12 years of age and over 5 mL (1 teaspoon) every 4 hours children under 12 years of age do not use

Storage and handling

• 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.

Label contents#

Full prescribing information#

Active ingredients(in each 5 mL 1 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg
Guaifenesin 388 mg
Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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.

OTC - 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

adults and children 12 years
of age and over
5 mL (1 teaspoon)
every 4 hours
children under 12 years
of age
do not use

Other information

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUSSLINTUSSLIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2728493dextromethorphan HBr 20 MG / guaiFENesin 388 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSN1
2728493dextromethorphan hydrobromide 4 MG/ML / guaifenesin 77.6 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCD1
2728493dextromethorphan HBr 20 MG / guaifenesin 388 MG / phenylephrine HCl 10 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-624-16TUSSLIN473 mL in 1 BOTTLE, PLASTICSYRUP4731

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-62452083-624-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUSSLINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKramer Novis987e19a5-032f-44e9-b4c7-8a764d5026952025-12-03WarningsExact identifier
ndc (package): 52083-624-16
ndc (product): 52083-624
ndc11 (package): 52083062416
spl id: 2d816a62-defd-4fa4-8809-73fb009e0394
spl set id: 987e19a5-032f-44e9-b4c7-8a764d502695

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.