TUSICOF- dextromethorphan, guaifenesin, 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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TUSICOF

COUGH SUPPRESSANT - EXPECTORANT
NASAL DECONGESTANT

Drug Facts

Active ingredients (in each 5mL tsp)Purpose
Dextromethorphan Hydrobromide, 20 mgCough suppressant
Guaifenesin, 400 mgExpectorant
Phenylephrine HCl, 10 mgNasal Decongestant

Uses

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

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

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 illness.

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

Artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralose

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

PRINCIPAL DISPLAY PANEL - TUSICOF

Principal Display Panel

NDC 52083-239-16

TUSICOF

COUGH SUPPRESSANT - EXPECTORANT
NASAL DECONGESTANT

SUGAR & ALCOHOL FREE

NO SACCHARIN - NO SORBITOL - NO ASPARTAME - NO DYE - NO PPA

16 Fl. oz. (474 mL)
Kramer Novis

Pharmaceuticals within reach of patients

TUSICOF 
dextromethorphan, guaifenesin, and phenylephrine syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-239
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-239-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2010
2NDC:52083-239-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2010
3NDC:52083-239-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/2010
Labeler - Kramer Novis (090158395)
Registrant - Kramer Novis (090158395)

Revised: 11/2019
Document Id: 1043a161-b529-4a8a-99ca-61d57419b7ec
Set id: e966b75c-4bb4-4216-8247-baada8f5d759
Version: 5
Effective Time: 20191113
 
Kramer Novis