TUSICOF- guaifenesin, phenylephrine hcl, dextromethorphan tablet, coated

Tusicof by

Drug Labeling and Warnings

Tusicof by is a Otc medication manufactured, distributed, or labeled by Kramer Novis.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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

• 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 acid

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

TUSICOF 
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)