Details for: NIGHTTIME PAIN RELIEF
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02424630 | NIGHTTIME PAIN RELIEF | IBUPROFEN (IBUPROFEN, IBUPROFEN POTASSIUM); DIPHENHYDRAMINE HYDROCHLORIDE | 200 MG; 25 MG | CAPSULE | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ABOUT THIS MEDICATION
- For fast and effective temporary 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
Contains two drugs: ibuprofen (a pain reliever for short term use) and diphenhydramine hydrochloride (a sleep-aid for sleeplessness). Pain relief from ibuprofen helps to fall asleep, and diphenhydramine helps to stay asleep.
When it should not be used
Do not use if:
- You are allergic/hypersensitive to ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA) or other salicylates, diphenhydramine or to any ingredient in the formulation or component of the container, or any of Nighttime Pain Relief ingredients (Refer to the nonmedicinal ingredients on outer carton or composition section)
- You have pain that does not keep you from sleeping.
- You have sleeplessness but are not in pain.
- You have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis).
- You have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms
- You have serious liver or kidney disease
- You have high potassium in the blood
- You are taking, ASA, acetaminophen, or other NSAIDs, such as naproxen or other ibuprofen product, antihistamines and or diphenhydramine containing products, (e.g. for cough & cold, sleep aids, etc.), monoamine oxidase inhibitors (MAOIs)
- You are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake
- You have heart problems, such as high blood pressure or severe coronary artery disease,
- right before or after heart surgery,
- You have System Lupus Erythematosus,
- You are in your third trimester of pregnancy.
What the medicinal ingredient is
Ibuprofen (present as free acid and potassium salt) and diphenhydramine hydrochloride.
What the non-medicinal ingredients are
D&C Red No. 33, FD&C Blue No. 1, gelatin, mannitol, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol.
What dosage form it comes in
Each liquid gel capsule contains ibuprofen 200 mg (present as free acid and potassium salt) and diphenhydramine hydrochloride 25 mg.
Warnings and precautions
Serious Warnings and Precautions
Causes sedation or sleepiness. Not for daytime use.
Caution in patients prone to gastrointestinal tract
irritation, including those with a history of peptic
ulcers. The chance of stomach bleeding is higher if
you are: age 60 or older, have had stomach ulcers or
bleeding problems, take a blood thinner or steroid
drug, take with other drugs containing an NSAID like
acetylsalicyclic acid (ASA), ibuprofen, naproxen, or
prescription anti-inflammatory drugs, have 3 or more
alcoholic drinks every day while using this product.
Patients at risk of kidney problems, including the
elderly or those using diuretics.
Use during pregnancy or nursing should be avoided.
Stop use immediately if you have difficulty or pain
when urinating.
BEFORE use, talk to your doctor or pharmacist if you have/are:
- previous or current stomach ulcers, diabetes, thyroid disease, mild to moderate kidney disease, mild to moderate liver disease, heart disease, glaucoma, breathing problems or chronic lung disease (such as asthma, emphysema or chronic bronchitis), blood clotting disorder (such as hemophilia), difficulty in urination due to prostate enlargement or bladder neck obstruction, any other serious condition, are taking any other prescription or over-the-counter drug, including any other anti-inflammatory medication
- Autoimmune disease (e.g. lupus)
- High blood pressure
- Over 65 years of age
- You are trying to conceive, in your first or second trimester of pregnancy or if you are breastfeeding
- 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 this product, do not drive motor vehicle or
operate machinery.
Use with caution in the elderly
Long-term continuous use may increase the risk of heart
attack or stroke.
Interactions with this medication
Do not use this product 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.
Drugs that may interact with Nighttime Pain
Relief include:
Acetaminophen, anticoagulants (blood thinners),
apomorphine, alcohol, digoxin, antidiabetic agents (oral)
and insulin, diuretics, methotrexate, lithium, probenecid,
thyroxine, antibiotics (e.g. cyclosporine), phenytoin,
corticosteroids, benzodiazepines, blood pressure
medications, depression medications, monoamine oxidase
inhibitors (MAOIs), antihistamines (such as allergy
medications), tranquilizers, alcohol or other sedating drugs,
NSAIDs (including naproxen and ibuprofen), sleep-aids,
cold medications
Do not take this product at the same time as other
medications containing pain relievers (e.g., ibuprofen,
ASA, acetaminophen, naproxen, etc.) or
diphenhydramine (e.g., allergy medications, sedating
drugs, cough/cold/flu medications, antinausea drugs) etc.
Proper use of this medication
Usual Dose
Adults and children 16 to 65 years: Take a single dose of 1
or 2 Nighttime Pain Relief capsules at night. Do not take
more than the recommended dosage unless directed by a
physician. Do not exceed 1200 mg of ibuprofen and 300
mg of diphenhydramine (including the 200-400 mg
ibuprofen and 25-50 mg diphenhydramine hydrochloride
from Nighttime Pain Relief dose) in 24 hours. Should be
taken no sooner than 4-6 hours after the last daytime
ibuprofen or diphenhydramine dose. See Interactions
with this Medication for examples of other products which contain these ingredients. Do not take
for
more than 5
consecutive nights unless directed by a physician.
Do not give to children under 16 unless directed by a
physician.
Do not use longer than 3 days for a fever or 5 days for
pain or cold symptoms.
Overdose
If you think you have taken too much Nighttime Pain Relief, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
Take once at night before bedtime. Do not take twice the recommended dose after a missed dose.
Side effects and what to do about them
Take with food or milk if upset stomach occurs.
If abdominal pain, heartburn, nausea or vomiting, bloating,
diarrhea or constipation, ringing or buzzing in the ears,
nervousness, sleeplessness, dizziness, any change in
vision, fluid retention, shortness of breath, wheezing, any
trouble breathing or chest tightness, hives, swelling or
itching, skin rashes, skin reddening, blisters, blood in
vomit, bloody or black stools, jaundice (yellowing of the
eyes or skin due to liver problem), or any other side effect
or unexplained symptoms develop while taking Nighttime
Pain Relief, discontinue use immediately and contact a
physician.
Side effects may be minimized by using the smallest dose
for the shortest duration of time.
Consult your physician if the symptoms of pain or
sleeplessness persist for more than 5 days.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
STOP USE and consult your physician 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 Nighttime Pain Relief, contact your doctor or pharmacist.
How to store
Store at room temperature 15°C-30°C. Protect from light.
Keep out of reach of children. This package contains
enough medicine to seriously harm a child.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about Nighttime Pain Relief:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario,
M9L 1T9
Last revised: February 11, 2021