Label: TUSICOF- guaifenesin, phenylephrine hcl, dextromethorphan 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
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.
Updated December 15, 2018
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- Drug Facts
- Active Ingredients (in each caplet)
Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg
Phenylephrine HCl, 10 mgClose
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves these symptoms occurring with a cold:
- nasal congestions
- cough due to minor throat and bronchial irritation
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
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.Close
- Other Information
- Tamper evident feature: Do not use if packet is torn, cut or open.
- Store at controlled room temperature 15-30°C (59-86°F).
- Avoid excessive heat and humidity.
- Inactive Ingredients
Hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acidClose
- SPL UNCLASSIFIED SECTION
SUGAR & DYE FREE
Manufactured in the USA for Kramer Novis
San Juan, PR 00917. Tel: (787) 767-2072
- 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 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 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 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; Type 0: Not a Combination Product 07/18/2012 2 NDC:52083-289-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2012 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)