TUSICOF- guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated 
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.

----------

TUSICOF®

Drug Facts

Active Ingredients (in each caplet)

Dextromethorphan HBr, 20 mg

Guaifenesin, 400 mg

Phenylephrine HCl, 10 mg

Purpose

Cough suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not use if you are 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 exceed recommended dose.

Stop use and ask a doctor if
• symptoms do not improve • new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Directions

Adults and children 12 years of age or older: Take 1 caplet every 4 hours as needed, do not exceed 6 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor.

Other Information

Inactive Ingredients

Hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Phenylphrine HCL

NASAL DECONGESTANT

SUGAR & DYE FREE

Manufactured in the USA for Kramer Novis

San Juan, PR 00917. Tel: (787) 767-2072

www.kramernovis.com

Packaging

Tusicofnw

TUSICOF 
guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-289
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (snow white) Score2 pieces
ShapeCAPSULE (T) Size19mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-289-022 in 1 PACKET; Type 0: Not a Combination Product07/18/2012
2NDC:52083-289-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/18/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/18/2012
Labeler - Kramer Novis. (090158395)

Revised: 12/2018
Document Id: 9f336526-25df-419b-9cc9-b08d7ab5f0f0
Set id: e6391d61-36ea-4926-878c-6758f65caa7e
Version: 3
Effective Time: 20181215
 
Kramer Novis.