Patient Medication Information: uses, side effects, how to take - Nighttime Cold, Cough & Flu
ABOUT THIS MEDICATION
What the medication is used for:
Nighttime Cold, Cough & Flu is used for the temporary relief of the symptoms associated with colds and influenza (the “flu”):
- Dry Coughs
- Sneezing
- Runny nose
- Fever and Chills
- Headache
- Body aches and pains
- Sore throat pain
What it does:
Contains two drugs: ibuprofen (relieves pain and fever) and diphenhydramine hydrochloride (antihistamine and cough suppressant).
When it should not be used:
Do not use if you have or are:
- Active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system (e.g. crohn’s, colitis) or gastrointestinal bleeding.
- Nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), uticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms,
- Taking, acetylsalicylic acid (ASA), acetaminophen, or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs), such as naproxen or other ibuprofen product.
- Known or suspected hypersensitivity or allergy to ibuprofen or other NSAIDs, ASA or other salicylates, diphenhydramine or to any ingredient in the formulation.
- Dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
Diagnosed with severe high blood pressure or have severe coronary artery disease, serious liver or kidney disease, Systemic Lupus Erythematosus.
Pregnant or nursing.
- Or right before or after heart surgery.
What the medicinal ingredients are:
Ibuprofen (present as free acid and potassium salt) and diphenhydramine hydrochloride.
What the nonmedicinal 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.
The capsule shells are imprinted with white edible ink and contain the non-medicinal ingredients: ammonium hydroxide, propylene glycol, shellac glaze, simethicone, and titanium dioxide.
What dosage forms 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 history of peptic ulcer.
BEFORE use, 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 disorder (such as hemophilia)
- Kidney or liver disease
- Any other serious disease
- Taking prescription or over-the-counter drug
- Over 65 years of age
- Pregnant or nursing a baby
While taking this product, do not drive motor vehicle or operate machinery.
If sore throat pain lasts more than two days, consult a doctor.
INTERACTIONS WITH THIS MEDICATION
Do not use Nighttime Cold, Cough & Flu 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 Nighttime Cold, Cough & Flu 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 diphenhydramine e.g., allergy medications, sedating drugs, cough/cold/flu medications, antinausea drugs) etc.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults≥16 to 65 years: Take a single dose of 1 or 2 Nighttime Cold, Cough & Flu capsules at night. Do not take more than the recommended dosage unless directed by a doctor. 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 Cold, Cough & Flu 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 use longer than 3 consecutive nights for a fever or 5 consecutive nights for pain or cold symptoms.
Do not give to children under 16 unless directed by a doctor.
Overdose:
| If you think you have taken too much Nighttime Cold, Cough & Flu, 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
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 Nighttime Cold, Cough & Flu, discontinue use immediately and contact a doctor.
Side effects may be minimized by using the smallest dose for the shortest duration of time.
Do not use a topically-applied diphenhydramine product at the same time as Nighttime Cold, Cough & Flu.
Tell your doctor or pharmacist what prescription drugs you are taking or plan to take.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
| 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 Nighttime Cold, Cough & Flu, contact your doctor or pharmacist.
HOW TO STORE IT
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
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). 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
For more information, please contact your doctor, pharmacist or other healthcare professional. This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.