Acetaminophendrug info

acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule

What it is used for

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate analgesics): Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses, reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 8, 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

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration.

Each capsule contains: Butalbital, USP 50 mg Acetaminophen, USP 325 mg Caffeine, USP 40 mg Codeine phosphate, USP 30 mg Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 MW 224.26 Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C 8 H 9 NO 2 MW 151.16 Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula: C 8 H 10 N 4 O 2 MW 194.19 Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula: C 18 H 24 NO 7 P anhydrous MW

397.37 Inactive

Ingredients: Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid, Talc. The gelatin capsules are printed with edible inks containing Titanium Dioxide, Gelatin, FD&C Blue No. 1, FD&C Red No. 40, and FD&C Yellow No. 5.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 8, 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.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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