butalbital and acetaminophen tablet

INDICATIONS AND USAGE Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

aace pharmaceuticals, inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] dyspnoea` `[3] nausea` `[4] drug ineffective` `[5] pain` `[6] diarrhoea` `[7] off label use` `[8] headache` `[9] dizziness` `[10] vomiting`

2 years ago

ROUND WHITE S 8

HOW SUPPLIED white to off white, round-shaped, biconvex tablets debossed “S8” on one side and plain on the other side, in bottles of 30 (NDC 71406-109-03) and in bottles of 500 (NDC 71406-109-05). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004 USA Rev. 00, 10/21

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butalbital and acetaminophen tablet

FDA Reported Adverse Reactions [1] fatigue [2] dyspnoea [3] nausea [4] drug ineffective [5] pain [6] diarrhoea [7] off label use [8] headache [9] dizziness [10] vomiting

ROUND WHITE S 8

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FDA Reported Adverse Reactions
`[1] fatigue` `[2] dyspnoea` `[3] nausea` `[4] drug ineffective` `[5] pain` `[6] diarrhoea` `[7] off label use` `[8] headache` `[9] dizziness` `[10] vomiting`