Tusslin®

Tusslin®
SPL v6
SPL
SPL Set ID 14a6e659-f97b-44c2-bcf7-5e017c7f4001
Route
ORAL
Published
Effective Date 2021-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (28 mg) Guaifenesin (388 mg) Phenylephrine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Methylparaben Propylparaben Polyethylene Glycol 1450 Polyethylene Glycol 400 Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-07-01

Description

Dextromethorphan HBr, 28 mg Guaifenesin, 388 mg Phenylephrine HCl, 10 mg

Purpose

Antitussive Expectorant Nasal Decongestant


Medication Information

Purpose

Antitussive Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 28 mg Guaifenesin, 388 mg Phenylephrine HCl, 10 mg

Uses
  • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make cough more productive • temporarily relieves nasal congestion due to a cold
Section 42229-5

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.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Antitussive

Expectorant

Nasal Decongestant

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.

Packaging

Directions

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

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

Drug Facts

Other Information
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Avoid excessive heat or humidity.
  • Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.
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

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg


Structured Label Content

Uses
  • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make cough more productive • temporarily relieves nasal congestion due to a cold
Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Antitussive

Expectorant

Nasal Decongestant

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.

Packaging

Directions

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

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

Drug Facts

Other Information (Other information)
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Avoid excessive heat or humidity.
  • Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

www.kramernovis.com

Active Ingredients (in Each 5 Ml Tsp) (Active Ingredients (in each 5 mL tsp))

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg


Advanced Ingredient Data


Raw Label Data

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