IBUPROFEN PM
Drug Labeling and Warnings
Drug Details [pdf]
IBUPROFEN PM- ibuprofen and diphenhydramine hcl capsule, liquid filled
LNK International, Inc.
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IBUPROFEN PM
ACTIVE INGREDIENT
(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
USES
- For relief of occasional 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 aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:
This product contains an 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 more or for a longer time than directed
DO NOT USE
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- unless you have time for a full night's sleep
- in children under 12 years of age
- right before or after heart surgery
- with any other product containing diphenhydramine, even one used on skin
- if you have sleeplessness without pain
ASK A DOCTOR BEFORE USE IF
- stomach bleeding warning applies to you
- 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 high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
- you are taking a diuretic
- you have a breathing problem such as emphysema or chronic bronchitis
- you have glaucoma
- you have trouble urinating due to an enlarged prostate gland
ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE
- taking sedatives or tranquilizers, or any other sleep-aid
- under a doctor's care for any continuing medical illness
- taking any other antihistamines
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
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 illness.
redness or swelling 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 medical 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
OTHER INFORMATION
- 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
INACTIVE INGREDIENT
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 PM
ibuprofen and diphenhydramine hcl capsule, liquid filled |
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| Labeler - LNK International, Inc. (038154464) |
| Registrant - Strides Pharma Science Limited (650738743) |