Nitetime label

Nitetime

Nitetime Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

  • For external use only
  • Flammable, keep away from fire and flame
  • Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances
  • Condition worsens
  • Redness or irritation develops
  • If condition persists for more than 3 days

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Nitetime Manufacturers

  • Puracap Pharmaceutical Llc
    Nitetime | Tri-coastal Design Company Inc.
    No Recall

    Nitetime | Tri-coastal Design Company Inc.

    Nitetime | Tri-coastal Design Company Inc.
    Rub dime sized amount between hands until dry Supervise children in the use of this product in the case of eye contact, rinse eyes thoroughly with water
  • Publix Super Markets Inc
    Nitetime | Publix Super Markets Inc
    No Recall

    Nitetime | Publix Super Markets Inc

    Nitetime | Publix Super Markets Inc
    take only as recommended – see Liver warning use dose cup do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Nitetime | Kroger Company
    No Recall

    Nitetime | Kroger Company

    Nitetime | Kroger Company
    take only as recommended – see Liver warning use dose cup do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL (2 TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Publix Super Markets Inc
    Nitetime | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Nitetime | Pd-rx Pharmaceuticals, Inc.

    Nitetime | Pd-rx Pharmaceuticals, Inc.

    Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

    After observing the response to initial therapy with oxaprozin tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

    Rheumatoid Arthritis

    For relief of the signs and symptoms of rheumatoid arthritis, the usual recommended dose is 1200 mg (two 600 mg tablets) given orally once a day (see Individualization of Dosage).

    Osteoarthritis

    For relief of the signs and symptoms of osteoarthritis, the usual recommended dose is 1200 mg (two 600 mg tablets) given orally once a day (see Individualization of Dosage).

    Juvenile Rheumatoid Arthritis

    For the relief of the signs and symptoms of JRA in patients 6 to 16 years of age, the recommended dose given orally once per day should be based on body weight of the patient as given in Table 3 (see also Individualization of Dosage).

    Table 3 Body Weight Range (kg) Dose (mg) 22 to 31 600 32 to 54 900 ≥ 55 1200

    (see CLINICAL PHARMACOLOGY, Special Populations, Pediatric Patients)

    Individualization of Dosage

    As with other NSAIDs, the lowest dose should be sought for each patient. Therefore, after observing the response to initial therapy with oxaprozin, the dose and frequency should be adjusted to suit an individual patient's needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of oxaprozin to minimize adverse effects. The maximum recommended total daily dose of oxaprozin in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied.

    Patients of low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring (see CLINICAL PHARMACOLOGY, Special Populations).

    In adults, in cases where a quick onset of action is important, the pharmacokinetics of oxaprozin allow therapy to be started with a one-time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with oxaprozin, although divided doses may be tried in patients unable to tolerate single doses.