G-P-TUSS DXP - dexbrompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride 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

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

Other information

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

Principal Display Panel

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 DEA Schedule     
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
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/24/2013
Labeler - Kramer Novis (090158395)

Revised: 1/2013
Document Id: cd027353-8669-4aac-b94f-d2ceb7456ef4
Set id: bedf9f6a-02d2-488a-beeb-73fbdb2789da
Version: 1
Effective Time: 20130124
 
Kramer Novis