Tusslin
- Manufacturer
- Kramer Novis
- Effective date
- 2019-09-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:00:31
Label at a glance#
ProductTusslin Pediatric
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections
Contacts and useful links#
Websitewww.kramernovis.com
www.kramernovis.com
www.kramernovis.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each 1 mL) Purpose
Dextromethorphan HBr, 7.5 mg..............................Antitussive
Guaifenesin, 88 mg..............................................Expectorant
Phenylephrine HCl, 2.5 mg................................Nasal decongestant
OTC - PURPOSE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- nasal congestion due to the common cold
- cough due to minor throat and bronchial irritation as may occur with the common cold
WARNINGS SECTION
Warnings
Do not use
in child who is 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 child's prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product.
OTC - DO NOT USE SECTION
Ask a doctor before use if your child has
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with asthma
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
- new symptoms occur
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 accidental overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
do not use more than 4 doses in any 24-hour period
Children 6 to under 12 years of age
- 2 mL every 6 hours, do not exceed 4 doses.
Children 2 to under 6 years of age
- 1 mL every 6 hours, do not exceed 4 doses, or as directed by a doctor.
Children under 2, consult a doctor
- measure with the dosage device provided. Do not use any other device.
INDICATIONS & USAGE SECTION
Other information
Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat and humidity.
INACTIVE INGREDIENT SECTION
Inactive ingredients Citric acid, flavors, menthol, methyl paraben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propyl paraben, purified water, sorbitol and sucralose.
OTC - QUESTIONS SECTION
Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.
Tel: (787) 767-2072 www.kramernovis.com
Principal Display Panel
TUSSLIN®
PEDIATRIC DROPS
Contains the same active ingredients as Glituss® Pediatric
Antitussive
Expectorant
Nasal Decongestant
Sugar, Alcohol & Dye Free
NET CONTENT: 30 mL (1 Fl. Oz.)
KRAMER-NOVIS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1487369 | dextromethorphan HBr 7.5 MG / guaiFENesin 88 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution | PSN | 3 |
| 1487369 | dextromethorphan hydrobromide 7.5 MG/ML / guaifenesin 88 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution | SCD | 3 |
| 1487369 | dextromethorphan HBr 7.5 MG / guaifenesin 88 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52083-623-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9ec1-d83d-e063-dadaa90ab31f | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-623-01 | TusslinPediatric | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| AMMONIUM GLYCYRRHIZATE | INACTIVE INGREDIENT | 3VRD35U26C | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Tusslin Pediatric
- Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CITRIC ACID MONOHYDRATE
- METHYLPARABEN
- AMMONIUM GLYCYRRHIZATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52083-623 | 52083-623-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | LOZENGE / ORAL | 115 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAPLEURAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / VAGINAL | 0.49 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | ELIXIR / ORAL | 100 mg/5ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAVENOUS | 2068 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a5539e41-632f-4d48-8a49-1d93e5c531be | 6fe91407-08c1-465b-9c00-251c94b1f7f0 | 2019-09-16 | Warnings | a5539e41-632f-4d48-8a49-1d93e5c531be 6fe91407-08c1-465b-9c00-251c94b1f7f0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.