IBUPROFEN AND DIPHENHYDRAMINE HCL
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ibuprofen and
diphenhydramine hydrochloride capsule, liquid filled
Strides Arcolab Limited
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(In each capsule)
Diphenhydramine hydrochloride 25 mg
Solubilized Ibuprofen equal to Ibuprofen 200 mg (NSAID)* (Present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you
• you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear
ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of medical overdose, get medical help or contact a Poison Control Center right away.
• Each capsule contains: potassium 20 mg
• Read all warnings and directions before use. Keep carton.
• Store at 20-25°C (68-77°F)
• Avoid excessive heat above 40°C (104°F)
• Protect from light
Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.
Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.
IBUPROFEN AND DIPHENHYDRAMINE HCL
ibuprofen and diphenhydramine hcl capsule, liquid filled |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA200888 | 03/05/2012 |
Labeler - Strides Arcolab Limited (650738743) |
Registrant - Strides Arcolab Limited (650738743) |
Revised: 10/2012 Strides Arcolab Limited