Label: TUSICOF - guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride tablet, coated
- NDC Code(s): 52083-289-02, 52083-289-60
- Packager: Kramer Novis.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- ACTIVE INGREDIENT
Active Ingredients (In Each Tablet)Close
Guaifenesein 400 mg
Phenylephrine HCl 10 mg
Dextromethorphan HBr. 20 mg
Expectorant, nasal decongestant, antitussive (anti cough)Close
- INDICATIONS & USAGE
Uses: temporarily relieves these symptoms occurring with a cold
nasal decongestion: cough due to minor throat and bronchial irritationClose
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- DOSAGE & ADMINISTRATION
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
• 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
• 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
• 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)
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding baby, ask a health professionalClose
- KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN. In case of overdose,Close
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 INGREDIENT
Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Stearic AcidClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
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)