Drug Labeling and Warnings

Drug Details [pdf]

G-P-TUSS DXP- dexbrompheniramine, dextromethorphan, and phenylephrine syrup 
Kramer Novis

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

• Active ingredients (in each 5mL tsp): Purpose
• Dexbrompheniramine Maleate, 2 mg: Antihistamine
• Dextromethorphan Hydrobromide, 20 mg: Cough suppressant
• Phenylephrine HCl, 10 mg: Nasal Decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, watery eyes
  • nasal congestion
• temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
• temporarily restores freer breathing through nose

Warnings

Do not use

• 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 giving this product.

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• may cause marked drowsiness
• sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• new symptoms occur
• symptoms do not improve 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 accidental 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
• EVERY 4 HOURS
• Adults and Children 12 years of age and older: 5 mL (1 tsp)
• Children 6 to under 12 years of age: (2.5 mL (1/2 tsp)
• Children under 6 years of age: consult physician

Other information

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

Inactive ingredients

Ammonium glycyrrhizinate, D&C red #33, flavor, glycerin, hydroxyethylcellulose, methylparaben, polysorbate, propylparaben, purified water, and sucralose

Manufactured in the USA for Kramer Novis.
San Juan, PR 00917
Tel: (787) 767-2072 / www.kramernovis.com

PRINCIPAL DISPLAY PANEL - G-P-TUSS DXP

NDC: 52083-602-16

G-P-TUSS DXP

ANTIHISTAMINE
COUGH SUPPRESSANT
NASAL DECONGESTANT

ALCOHOL FREE
RASPBERRY FLAVOR

16 Fl. oz. (473 mL)
Kramer Novis

Pharmaceuticals within reach of patients

G-P-TUSS DXP 
dexbrompheniramine, dextromethorphan, and phenylephrine syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-602
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY (Raspberry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-602-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2013	05/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/24/2013	05/31/2017

Labeler - Kramer Novis (090158395)

Revised: 9/2019

Document Id: 6fba7dbf-aa33-434f-b21e-06ea303e966e

34390-5

Set id: bedf9f6a-02d2-488a-beeb-73fbdb2789da

Version: 2

Effective Time: 20190916

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