ADVIL PM
-
diphenhydramine citrate and
ibuprofen capsule, coated
Wyeth Consumer Healthcare
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Advil PM (diphenhydramine citrate and ibuprofen)DRUG FACTS
ACTIVE INGREDIENTS (IN EACH CAPLET)
*nonsteroidal anti-inflammatory drug
PURPOSES
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 you have
- a breathing problem such as emphysema or chronic bronchitis
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- heart or kidney disease
- asthma
- taken a diuretic
- reached age 60 or older
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers, or any other sleep-aid
- taking any other drug containing an NSAID (prescription or nonprescription)
- under a doctor’s care for any continuing medical illness
- taking any other antihistamines
- taking a blood thinning (anticoagulant) or steroid drug
- 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
- 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.
- stomach pain or upset gets worse or lasts
- 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 the 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
- do not take longer than 10 days, unless directed by a doctor (see WARNINGS)
- adults and children 12 years and over: take 2 caplets at bedtime.
- do not take more than 2 caplets in 24 hours
OTHER INFORMATION
- 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)
INACTIVE INGREDIENTS
calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
QUESTIONS OR COMMENTS?
Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL
PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.
Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
For most recent product information, visit www.Advil.com.
Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth
Appearance of the blue Advil PM caplet is a trademark of Wyeth Consumer Healthcare
| ADVIL PM
diphenhydramine citrate, ibuprofen capsule, coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021394 | 12/21/2005 | |
| Labeler - Wyeth Consumer Healthcare (828831730) |