Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. Acetaminophen, 4’ -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic.


Each VICODIN® ES (Hydrocodone Bitartate and Acetaminophen Tablets, USP 7.5 mg/300 mg) contains:

Hydrocodone Bitartrate…………7.5 mg
Acetaminophen…………………. 300 mg

Each VICODIN HP® (Hydrocodone Bitartate and Acetaminophen Tablets, USP 10 mg/300 mg) contains:

Hydrocodone Bitartrate………… 10 mg
Acetaminophen…………………. 300 mg.


In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.



Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.



Important Dosage And Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.


Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse .


Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly.


Initial Dosage

Initiating Treatment With Hydrocodone Bitartrate And Acetaminophen Tablets


7.5 mg/300 mg
The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed 6 tablets.
10 mg/300 mg
The usual adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed 6 tablets.



The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.


Other adverse reactions include:

Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes.

Gastrointestinal System: Constipation.

Genitourinary System: Ureteral spasm, spasm of vesical sphincters, and urinary retention.




Vicodin (Hydrocodone Bitartrate and Acetaminophen)


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