TUSSI PRES PEDIATRIC- guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup

TUSSI PRES PEDIATRIC by

Drug Labeling and Warnings

TUSSI PRES PEDIATRIC by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (In each 5 mL teaspoon)

Dextromethorphan HBr 5 mg

Guaifenesin 75 mg

Phenylephrine HCl 2.5 mg

Purpose

Antitussive (Anti-Cough)

Expectorant

Nasal Decongestant

Uses:

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. 

Temporarily relieves these symptoms occurring with a cold: nasal congestion and cough due to minor throat and bronchial irritation.

Warnings:

Do not use:  in a child under 2 years of age. in a 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 an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has:

heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema.

Do not use more than the recommended dose.

Stop use and ask a doctor if: your child gets 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.

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.

• Adults & Children 12 years of age and older: Take 4 teaspoons (20 mL) every 4 hours, as needed.
• Children 6 to under 12 years of age: Take 2 teaspoons (10 mL) every 4 hours, as needed.
• Children 2 to under 6: Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.
• Children under 2 years: Do not use.

Other Information:

Tamper Evident. Do not use if packet is torn, cut or opened.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Avoid excessive heat or humidity.

Inactive Ingredients:

Citric acid, Flavor, Glycerin, Methylparaben, Propylene glycol, Propylparaben, Purified water, Sodium citrate and Sucralose

SPL UNCLASSIFIED SECTION

COUGH SUPPRESSANT, EXPECTORANT, NASAL DECONGESTANT

SUGAR, ALCOHOL, SACCHARIN, SORBITOL & DYE FREE

ORANGE FLAVOR

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

1 (787) 767-2072 www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

TUSSI PRES PEDIATRIC 
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 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 CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (CITRUS ORANGE)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-232-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2011	07/12/2017
2	NDC: 52083-232-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2011	07/12/2017
3	NDC: 52083-232-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2011
4	NDC: 52083-232-05	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/24/2011

Labeler - KRAMER NOVIS (090158395)

Registrant - KRAMER NOVIS (090158395)