Ibuprofen Nighttime: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ibuprofen Daytime

Temporary relief of mild to moderate migraine headaches including associated symptoms of nausea, and sensitivity to light and sound.

Fast and effective relief of muscle aches and pain, joint and body pain, backache, muscle sprains and strains, pain of inflammation associated with conditions including arthritis and physical or athletic overexertion (e.g. sprains or strains), headache including tension headache, dental pain, menstrual pain.

Ibuprofen Nighttime

For fast and effective relief of occasional mild to moderate

nighttime pain and accompanying sleeplessness, due to minor

aches and pains associated with joints, muscles, backache,

headache and toothache as well as pain of migraine and arthritis.

For longer sleep, uninterrupted by temporary pain.

Only for temporary mild to moderate pain that causes

sleeplessness. If this is not the case, do not use.

What it does:

Ibuprofen Daytime contains ibuprofen (a pain reliever for short term use). Ibuprofen Nighttime contains ibuprofen (a pain reliever for short term use) and one extra ingredient, diphenhydramine hydrochloride (a sleep-aid for sleeplessness).

Liquid-fast relief.

When it should not be used:

Do not use if:

• you have peptic ulcer disease, a history of recurrent

ulceration active inflammatory disease of the

gastrointestinal system or gastrointestinal bleeding,

• are taking acetylsalicylic acid (ASA) or any other non-steroidal anti-inflammatory medication (NSAIDs), such as naproxen or other ibuprofen product,

  • are allergic to ibuprofen or other NSAIDs, ASA, other salicylates, diphenhydramine or any ingredient in the formulation (refer to the non-medicinal ingredients on outer carton or composition section),
  • you have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), urticarial/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms caused by salicylates or other NSAIDs
  • you are dehydrated (significant fluid loss) due to vomiting, diarrhea, or lack of fluid intake,
  • you have been diagnosed with severe high blood pressure or have severe coronary artery disease, serious liver or kidney disease, Systemic Lupus Erythematosus

  • you are pregnant or nursing.

Do not use Ibuprofen Nighttime if:

• You have pain that does not keep you from sleeping.
• You have sleeplessness but are not in pain.

What the medicinal ingredient is:

Ibuprofen Daytime: Ibuprofen (present as free acid and potassium salt).

Ibuprofen Nighttime: Ibuprofen (present as free acid and potassium salt) and diphenhydramine hydrochloride.

What the important nonmedicinal ingredients are:

Ibuprofen Daytime: FD&C green no. 3, gelatin, isopropyl alcohol, medium chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, povidone, purified water, sorbitan, sorbitol.

Ibuprofen Nighttime: D&C red #33, FD&C blue #1, gelatin, isopropyl alcohol, pharmaceutical ink, polyethylene glycol, potassium hydroxide, povidone, purified water, special sorbitol sorbitan solution.

What dosage forms it comes in:

Ibuprofen Daytime: Each liquid capsule contains 200 mg ibuprofen (present as free acid and potassium salt).

Ibuprofen Nighttime: Each liquid gel capsule contains ibuprofen 200 mg (as free acid and potassium salt) and diphenhydramine hydrochloride 25 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.
• Ibuprofen Nighttime causes sedation or sleepiness. Not for daytime use.

BEFORE you use Ibuprofen Daytime or Ibuprofen Nighttime talk to your doctor or pharmacist if you have /are:

• Diabetes
• Chronic lung disease
• Glaucoma
• Difficulty in urination due to an enlarged prostate
• Autoimmune disease (e.g. lupus)
• High blood pressure
• Heart disease
• Heart failure or thyroid disease
• Peptic ulcers
• Asthma
• Blood clotting disorders (such as hemophilia)
• Kidney or liver disease
• Any other serious disease
• Taking any other prescription or over-the-counter drug
• Over 65 years of age
• Pregnant or nursing a baby
• Sleeplessness due to mild to moderate pain persists continually for more than 5 days.

Insomnia may be a symptom of a serious underlying medical

condition other than pain.

While taking Ibuprofen Nighttime, do not drive motor vehicle or

operate machinery.

INTERACTIONS WITH THIS MEDICATION

Do not use Ibuprofen Daytime or Ibuprofen Nighttime if you are taking:

• Daily low dose ASA (81 – 325 mg), without talking to a
• doctor or pharmacist. Ibuprofen may interfere with the
• preventive benefits of ASA.
• ASA or other anti-inflammatory medication.

Drugs that may interact with Ibuprofen Daytime or Ibuprofen Nighttime include:

• Anticoagulants (blood thinners)
• Antihistamines, tranquilizers, alcohol or other sedating drugs
• Digoxin
• Diuretics (e.g., for bloating or heart conditions)
• Insulin
• Lithium
• Medications for high blood pressure or depression, including mononamine oxidase inhibitors (MAOIs)
• Methotrexate
• Oral antidiabetic agents
• Other NSAIDs
• Other pain relievers, sleep-aids or cold medicines
• Protein-bound drugs including probenecid, thyroxine, antibiotics (e.g. cyclosporine), phenytoin, corticosteroids or benzodiazapenes

Do not take this product at the same time as other medications

containing pain relievers (e.g., ibuprofen, ASA, acetaminophen,

naproxen, etc.) or diphenydramine (e.g., allergy medications,

sedating drugs, cough/cold/flu medications, antinausea drugs) etc.

Tell your doctor or pharmacist what prescription drugs you are taking or plan to take.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults ≥16 to 65 years of age: Ibuprofen Daytime:

Take 1 green liquid capsule every 4 hours or 2 green liquid capsules every 6 to 8 hours at the first sign of symptoms as needed. Ibuprofen Nighttime: Take 1 or 2 blue liquid capsules at night, 4 to 6 hours after the last Ibuprofen Daytime or diphenhydramine dose. Do not take for more than 5 consecutive days/nights unless directed by a doctor. Do not exceed a combined total of any 6 Ibuprofen Daytime or Ibuprofen Nighttime in 24 hours, unless directed by a doctor.

Do not give to children under 16 unless directed by a doctor.

Overdose:

In case of overdose, call a Poison Control Centre or a doctor immediately, even if there are no symptoms.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If heartburn, nausea or vomiting, bloating, diarrhea or

constipation, ringing or buzzing in the ears, nervousness, dizziness, fluid retention, or any other side effect or unexplained symptoms develop while taking Ibuprofen Daytime or Ibuprofen Nighttime discontinue use immediately and contact a doctor.

Talk to your doctor if the symptoms of pain or sleeplessness persist for more than 5 days.

Side effects may be minimized by using the smallest dose for the shortest duration of time.

STOP USE and consult your doctor immediately if you experience: abdominal pain, allergic reaction (itching, blisters, rashes, skin reddening, etc.), any change in vision, blood in vomit, bloody or black stools, bladder pain, hallucinations or difficulty speaking.

This is not a complete list of side effects. For any unexpected effects while taking Ibuprofen Daytime or Ibuprofen Nighttime, contact your doctor or pharmacist.

Reporting Side Effects

HOW TO STORE IT

Store at room temperature (15°C -30°C). Protect from light.

Keep out of the reach of children. This package contains enough medicine to seriously harm a child.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor:

Regulatory Affairs Department

Vita Health Products Inc.

150 Beghin Avenue

Winnipeg, Manitoba

R2J 3W2

Last prepared: January 30, 2015