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Hydrocodone Polistirex And Chlorpheniramine Polistirex (Tussicaps)

Trade Name : TussiCaps

Bausch Health US LLC

CAPSULE, EXTENDED RELEASE

Strength 108 mg/1mg/1

HYDROCODONE; CHLORPHENIRAMINE Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydrocodone Polistirex And Chlorpheniramine Polistirex (Tussicaps) which is also known as TussiCaps and Manufactured by Bausch Health US LLC. It is available in strength of 10; 8 mg/1; mg/1 per ml. Read more

Hydrocodone Polistirex And Chlorpheniramine Polistirex (Tussicaps) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Each full-strength TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsule contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. Each half-strength TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsule contains hydrocodone polistirex equivalent to 5 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg of chlorpheniramine maleate. TussiCaps extended-release capsules provide up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. TussiCapsextended-release capsules are for oral use only.
  • Hydrocodone Polistirex: sulfonated styrene-divinylbenzene copolymer complex with 4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6-one.
  • Chlorpheniramine Polistirex: sulfonated styrene-divinylbenzene copolymer complex with 2-[-chloro-u03b1-[2-(dimethylamino)ethyl]-benzyl]pyridine.
  • Inactive Ingredients: Butyl alcohol, dehydrated alcohol, gelatin, iron oxide black JPE, isopropyl alcohol, microcrystalline cellulose, propylene glycol, purified water, SDA 3A alcohol (27 CFR), shellac, shellac glaze-45% in SD-45 alcohol, strong ammonia solution, titanium dioxide, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2 aluminum lake, FD&C blue #2/indigo carmine aluminum lake, and FD&C red #40/allura red AC aluminum lake.
  • Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, and physical and psychological dependence.
  • Chlorpheniramine is an antihistamine drug (H receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.
  • Hydrocodone and chlorpheniramine release from TussiCapsu00ae extended-release capsules is controlled by use of an ion-exchange polymer matrix.
  • Following multiple dosing with hydrocodone polistirex and chlorpheniramine polistirex extended-release suspension, hydrocodone mean (S.D.) peak plasma concentrations of 22.8 (5.9) ng/mL occurred at 3.4 hours. Chlorpheniramine mean (S.D.) peak plasma concentrations of 58.4 (14.7) ng/mL occurred at 6.3 hours following multiple dosing. Peak plasma levels obtained with an immediate-release syrup occurred at approximately 1.5 hours for hydrocodone and 2.8 hours for chlorpheniramine. The plasma half-lives of hydrocodone and chlorpheniramine have been reported to be approximately 4 and 16 hours, respectively.
  • TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules are indicated for relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children 6 years of age and older.
  • TussiCaps extended-release capsules are contraindicated in patients with a known allergy or sensitivity to hydrocodone or chlorpheniramine.
  • The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age due to the risk of fatal respiratory depression.
  • Respiratory Depression u2013n- see u00a0
  • Head Injury and Increased Intracranial Pressure u2013
  • Acute Abdominal Conditions u2013
  • Obstructive Bowel Disease u2013
  • Pediatric Use
  • The use of TussiCaps extended-release capsules are contraindicated in children less than 6 years of age (n ).
  • In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Caution should be exercised when administering TussiCapsextended-release capsules to pediatric patients 6 years of age and older. Overdose or concomitant administration of TussiCaps extended-release capsules with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered, especially in pediatric patients with respiratory embarrassment (e.g., croup) (n ).
  • No data
  • Gastrointestinal Disorders
  • Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of TussiCaps extended-release capsules may produce constipation.
  • General Disorders and Administration Site Conditions
  • Death
  • Nervous System Disorders
  • Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes.
  • Renal and Urinary Disorders
  • Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates.
  • Respiratory, Thoracic and Mediastinal Disorders
  • Dryness of the pharynx, occasional tightness of the chest, and respiratory depression (n ).
  • TussiCaps extended-release capsules may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (n ). Use of TussiCaps in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with TussiCapsextended-release capsules in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.
  • Skin and Subcutaneous Tissue Disorders
  • Rash, pruritus.
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals, North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • TussiCaps extended-release capsules are Schedule II narcotics. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of narcotics; therefore, TussiCaps extended-release capsules should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when TussiCapsextended-release capsules are used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy.
  • Signs and Symptoms u2013
  • Treatment u2013
  • Adults and Children 12 Years and Older
  • One (1) full-strength TussiCaps extended-release capsule (hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate) every 12 hours; .
  • Children 6 to 11 Years of Age
  • One (1) half-strength TussiCaps extended-release capsule (hydrocodone polistirex equivalent to 5 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg of chlorpheniramine maleate) every 12 hours; .
  • This medicine is contraindicated in children under 6 years of age (n ).
  • Arrayn- Full-Strength: 10 mg/8 mg
  • TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules
  • Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with u201cECRu201d on the cap and u201cHP/CPu201d over u201c10/8u201d on the body.
  • Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0108-20
  • Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0108-01
  • Arrayn- Half-Strength: 5 mg/4 mg
  • TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules
  • Each half-strength capsule contains hydrocodone polistirex equivalent to 5 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 4 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in black with u201cECRu201d on the cap and u201cHP/CPu201d over u201c5/4u201d on the body.
  • Bottles of 20 . . . . . . . . . . . . . . . NDC 0187-0054-20
  • Bottles of 100 . . . . . . . . . . . . . . NDC 0187-0054-01
  • Storage:
  • Dispense in a well-closed container.
  • A Schedule CII Narcotic.
  • Manufactured for: ECR Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA
  • Manufactured By:SpecGx LLCHobart, NY 13788 USA
  • TussiCaps is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
  • u00a9 Valeant Pharmaceuticals North America LLC
  • 9417901 Rev. 03/2018
  • MG #35890
  • u00a0NDC 0187-0108-01u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • TussiCapsCII
  • (Hydrocodone Polistirex andChlorpheniramine Polistirex)n- Extended-Release Capsules
  • 10 mg/8 mg (full-strength)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Contraindicated in children under 6 years of age.
  • Each capsule contains: Hydrocodone Polisitrex equivalent to 10 mg hydrocodone bitartrate
  • Chlorpheniramine Polisitrex equivalent to 8 mg chlorpheniramine maleate
  • This package is not for household use.
  • Rx only
  • u00a9 Valeant Pharmaceuticals North America LLC
  • NDC 0187-0054-01u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • TussiCapsCII
  • (Hydrocodone Polistirex and Chlorpheniramine Polistirex)n- Extended-Release Capsules
  • 5 mg/4 mg (half-strength)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Contraindicated in children under 6 years of age.
  • Each capsule contains: Hydrocodone Polisitrex equivalent to 5 mg hydrocodone bitartrate Chlorpheniramine Polisitrex equivalent to 4 mgu00a0chlorpheniramine maleate
  • This package is not for household use.
  • Rx only

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