TUSICOF - guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride 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.

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Drug facts

Active Ingredients (In Each Tablet)
Guaifenesein 400 mg
Phenylephrine HCl 10 mg
Dextromethorphan HBr. 20 mg

Expectorant, nasal decongestant, antitussive (anti cough)

Uses: temporarily relieves these symptoms occurring with a cold

nasal decongestion: cough due to minor throat and bronchial irritation

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions:
Adults and children 12 years of age and older
• Take 1 tablet every 4 hours as needed, do not exceed 6
tablets in 24 hours, or as directed by a doctor.
• Children under 12 years, consult a doctor
• Warnings:

Warnings:
• when using this product do not exceed recommended dose.
• 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 MAOI drug. If you do not know if your prescription
drug contains an MAOI, consult a doctor or pharmacist before
taking this product
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 a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

If pregnant or breast-feeding baby, 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.
Prompt medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.

Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Stearic Acid

MM1
Tusicof Caplet




TUSICOF 
guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-289
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color white (snow white) Score 2 pieces
Shape CAPSULE (T) Size 19mm
Flavor Imprint Code T
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52083-289-02 2 in 1 PACKET
2 NDC:52083-289-60 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/18/2012
Labeler - Kramer Novis. (090158395)
Registrant - Ultraseal Corporation (085752004)
Establishment
Name Address ID/FEI Business Operations
Ultratab Laboratories, Inc. 151051757 manufacture(52083-289)

Revised: 8/2012
Document Id: 6a9b9b21-64a8-4325-a6e2-d84a1b8ac28d
Set id: e6391d61-36ea-4926-878c-6758f65caa7e
Version: 1
Effective Time: 20120814
 
Kramer Novis.