Promethazine Hydrochloride And Codeine Phosphate (Promethazine Hydrochloride And Codeine Phosphate)

Trade Name : PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Pharmaceutical Associates, Inc.

SYRUP

Strength 6.2510 mg/5mLmg/5mL

PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Delivery Process

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Disclaimer

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 Promethazine Hydrochloride And Codeine Phosphate (Promethazine Hydrochloride And Codeine Phosphate) which is also known as PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 6.25; 10 mg/5mL; mg/5mL per ml. Read more

Promethazine Hydrochloride And Codeine Phosphate (Promethazine Hydrochloride And Codeine Phosphate) 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

Validated Cold Chain Shipment

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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  • Rx ONLY
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  • Each 5 mL (one teaspoonful), for oral administration contains: promethazine hydrochloride 6.25 mg, codeine phosphate 10 mg, and alcohol 7%.
  • Inactive Ingredients: Citric acid, D&C Red No. 33, FD&C Blue No.1, FD&C Red No. 40, flavoring, glycerin, purified water, sodium benzoate, sodium citrate, saccharin, and sorbitol solution.
  • Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6u03b1-ol phosphate (1:1)(salt) hemihydrate.
  • The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of CHNOu2022HPOu2022u00bdHO, and the following structural formula:
  • Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (u00b1)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.
  • Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of CHNSu2022HCl, and the following structural formula:
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  • Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
  • The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
  • Codeine is contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.
  • Codeine is contraindicated in patients with a known hypersensitivity to the drug.
  • Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.
  • Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.
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  • Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed.
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  • The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
  • It is important that promethazine hydrochloride and codeine phosphate syrup is measured with an accurate measuring device (). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
  • The average effective dose for adults and children 12 years of age and older is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
  • The average effective dose for children 6 years to under 12 years of age is: u00bd to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
  • Promethazine hydrochloride and codeine phosphate syrup (clear purple color, grape flavor) contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7%, and is available in the following oral dosage form: NDC 0121-0547-05 (unit dose cups of 5 mL, 10 u00d7 10's).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP.
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  • R02/13
  • Pharmaceutical Associates, Inc.
  • Delivers n NDC 0121-0547-05
  • Pn- ROMETHAZINEn- HCland Cn- ODEINEn- PHn- OSPHATn- ESn- YRUP
  • CV
  • Each 5 mL contains: Codeine Phosphate 10 mgPromethazine HCl 6.25 mg and Alcohol 7%FOR INSTITUTIONAL USE ONLY
  • Rx ONLY
  • SEE INSERT
  • A05470500

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