SPL Set ID: 570974d4-0d5b-4df2-b307-37380511835d

1 drug(s) with this SPL Set ID

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Naproxen NAPROXEN
#49 125 mg/5 ml Suspension
AUROBINDO PHARMA LIMITED FDA Rx Only

Naproxen oral suspension, USP is available as a light orange-colored, pineapple-orange flavored homogenous suspension containing 125 mg/5 mL of naproxen USP for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. The molecular weight is 230.26. Its molecular formula is C 14 H 14 O 3 , and it has the following chemical structure. Naproxen USP is a white to off-white crystalline powder. It is soluble in chloroform, in dehydrated alcohol, and in alcohol, sparingly soluble in ether, practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen oral suspension USP include art pineapple flavor, benzyl alcohol, FD&C yellow No. 6, fumaric acid, magnesium aluminum silicate, methylparaben, modified food starch (corn), nat orange flavor, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium chloride (39 mg/5 mL, 0.667 mEq), sucrose, and xanthan gum. The pH of the suspension ranges from 2.2 to 3.7. str

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