Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (7.5 mg) Guaifenesin (88 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Citric Acid Monohydrate Methylparaben Ammonium Glycyrrhizate Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-01-27

Medication Information

Warnings and Precautions

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.

Indications and Usage

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.

Dosage and Administration

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.

Description

Active Ingredients (in each 1 mL) Purpose Dextromethorphan HBr, 7.5 mg..............................Antitussive Guaifenesin, 88 mg..............................................Expectorant Phenylephrine HCl, 2.5 mg................................Nasal decongestant

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.

Section 50570-1

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.

Section 51727-6

Inactive ingredients Citric acid, flavors, menthol, methyl paraben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propyl paraben, purified water, sorbitol and sucralose.

Section 53413-1

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.

Tel: (787) 767-2072

www.kramernovis.com

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

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

Section 55106-9

Active Ingredients (in each 1 mL) Purpose

Dextromethorphan HBr, 7.5 mg..............................Antitussive

Guaifenesin, 88 mg..............................................Expectorant

Phenylephrine HCl, 2.5 mg................................Nasal decongestant

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

Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients Citric acid, flavors, menthol, methyl paraben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propyl paraben, purified water, sorbitol and sucralose.

Section 53413-1 (53413-1)

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.

Tel: (787) 767-2072

www.kramernovis.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Active Ingredients (in each 1 mL) Purpose

Dextromethorphan HBr, 7.5 mg..............................Antitussive

Guaifenesin, 88 mg..............................................Expectorant

Phenylephrine HCl, 2.5 mg................................Nasal decongestant

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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.", "34068-7": "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.", "34071-1": "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.", "50565-1": "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "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.", "51727-6": "Inactive ingredients Citric acid, flavors, menthol, methyl paraben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propyl paraben, purified water, sorbitol and sucralose.", "53413-1": "Manufactured in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072 www.kramernovis.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "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", "55106-9": "Active Ingredients (in each 1 mL) Purpose Dextromethorphan HBr, 7.5 mg..............................Antitussive Guaifenesin, 88 mg..............................................Expectorant Phenylephrine HCl, 2.5 mg................................Nasal decongestant", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information