Ibuprofen PM
Quality Plus 44-611
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredients (in each capsule)
- Purpose
- Ibuprofen PM Uses
- Warnings
- Directions
- Ibuprofen PM Other information
- Inactive ingredients
- Questions or comments?
- Principal display panel
FULL PRESCRIBING INFORMATION
Active ingredients (in each capsule)
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*non steroidal anti-inflammatory drug
Purpose
Nighttime sleep-aid
Pain reliever
Ibuprofen PM Uses
- for relief of occassional sleeplessness when associated with minor aches and pains
- helps you fall asleep and stay asleep
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirn. Symptoms may include:
- rash
- facial swelling
- blisters
- hives
- skin reddening
- shock
- asthma (wheezing)
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant ) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take nore or for a longer time than directed
Do not use
- if you have ever had an allergic reaciton to any other pain reliever/fever reducer
- unless you have time for a full night's sleep
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- night before or after heart surgery
- if you have sleeplessness without pain
Ask a doctor before use if
- if you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have hight blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
- you are taking a diuretic
- you have glaucoma
- you have a breathing problem such as emphysema or chronic bronchitis
- stomach bleeding warning applies to you
- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilziers, or any other sleep-aid
- under a doctor's care ofr any continuingmedical illness
- taking any other antihistamines
- taking any other drug
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- 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 problem.
- redness or swellig is present in the painful area
- any new symptoms appear
If pregnant or breast-feeding,
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- adults and children 12 years and over: take 2 capsules at bedtime
- do not take more than 2 capsules in 24 hours
Ibuprofen PM Other information
- each capsule contains: potassium 20 mg
- read all warnings and directions before use.
Keep carton - store at 20º-25ºC (68º-77ºF)
- protect from light
- avoid excessive head above 40ºC (104ºF)
Inactive ingredients
anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, hydrolysed glatin, medium chain triglyceride, opacode white ink, polyethylene glycol 600, potassium hydroxide, purifed water.
ingredients of opacode white ink: lecithin (soya), n-butyl alcohol, purified water, shellac glaze in ehtanol, simethicone and titanium dioxide.
Questions or comments?
Call 1-800-426-9391 8:30 AM-4:00PM ET, Monday-Friday
Principal display panel
QUALITY PLUS
NDC 50844-611-19
†Compare to the active ingredients in Advil® PM LIQUI-GELS®
IBUPROFEN PM
SOFTGELS
Ibuprofen 200 mg / Diphenhydramine HCl 25 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid
SEE NEW WARNINGS INFORMATION
8 Softgels**
**Liquid Filled Capsules
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.
50844 ORG111261119
Product of India
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING
Ibuprofen PMDiphenhydramine hydrochloride, ibuprofen CAPSULE, LIQUID FILLED
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