Homatropinedrug info
homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG Oral Tablet
What it is used for
Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.
Limitations of Use: Not indicated for pediatric patients under 18 years of age. Contraindicated in pediatric patients less than 6 years of age. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough. Hydrocodone bitartrate and homatropine methylbromide is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 25, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP for oral administration. Hydrocodone bitartrate and homatropine methylbromide tablets, USP also contain: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and pregelatinized starch. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: cherry flavor, FD&C Red #40, glycerin, hydrochloric acid, maltitol syrup, purified water, sodium benzoate, sorbitol, and sucralose. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Hydrocodone Bitartrate The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure: Homatropine Methylbromide The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure: chemical-structure-hb chemical-structure-hm
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 25, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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