SPL Set ID: 6e0e8abc-512b-42f7-8323-434c589edecf

1 drug(s) with this SPL Set ID

Open DailyMed details

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate BUTALBITAL ACETAMINOPHEN CAFFEINE AND CODEINE PHOSPHATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg Codeine Phosphate, USP………….30 mg Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain: Butalbital, USP……………………50 mg Acetaminophen, USP…………….325 mg Caffeine, USP……………………..40 mg Codeine Phosphate, USP………….30 mg Butalbital, USP (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, USP (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, USP (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, USP (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 21 NO 3 •H 3 PO 4 •1/2H 2 O MW = 406.37 Inactive Ingredients : pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg. image-butalbital-usp-chem-structure image-acetaminophen-usp-chem-structure image-caffeine-usp-chem-structure codeine-phosphate-structural-formula

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