PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Available from:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

DEXTROMETHORPHAN HYDROBROMIDE

Composition:

DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS, Drug Interactions ). 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 are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

Product summary:

This preparation is a clear, yellow colored syrup, containing Promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in one pint (473 mL) bottles (NDC 60432-604-16). Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Rx Only Product No.: 7604 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 Manufactured By:                                                                             Morton Grove Pharmaceuticals, Inc.                                                                                   Morton Grove, IL 60053 A50-7604-16 REV. 07-18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE -
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP
MORTON GROVE PHARMACEUTICALS, INC.
----------
PROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP
(PROMETHAZINE HYDROCHLORIDE 6.25 MG/5 ML & DEXTROMETHORPHAN
HYDROBROMIDE 15 MG/5 ML)
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful), for oral administration contains:
Dextromethorphan hydrobromide 15 mg;
promethazine hydrochloride 6.25 mg. Alcohol 7.0%.
Inactive Ingredients: artificial pineapple flavor, artificial
raspberry flavor, ascorbic acid, citric acid
anhydrous, dehydrated alcohol, D&C Yellow No. 10, edetate disodium,
FD&C Yellow No. 6, glycerin,
liquid sugar, methylparaben, purified water, saccharin sodium, sodium
benzoate, sodium citrate
dihydrate and sodium propionate.
Dextromethorphan hydrobromide is a salt of the methyl ether of the
dextrorotatory isomer of
levorphanol, a narcotic analgesic. It is chemically designated as
3-Methoxy-17-methyl-9α, 13α, 14α-
morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide
occurs as white crystals
sparingly soluble in water and freely soluble in alcohol. It has a
molecular weight of 370.32, a
molecular formula of C
H NO•HBr•H O, and the following structural formula:
Promethazine is a racemic compound. Promethazine hydrochloride, a
phenothiazine derivative, is
chemically designated as 10_H_-Phenothiazine-10-ethanamine, _N_,_N_,
α-trimethyl-, 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 C
H N S•HCl, and
the following structural formula:
18
25
2
17
20
2
CLINICAL PHARMACOLOGY
DEXTROMETHORPHAN
Dextromethorphan is an antitussive agent and, unlike the isomeric
levorphanol, it has no analgesic or
addictive properties.
The drug acts centrally and elevates the threshold for