CVS IBUPROFEN PM
-
diphenhydramine citrate and
ibuprofen tablet, coated
CVS Pharmacy
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CVS Pharmacy, Inc. Ibuprofen PM Caplets Drug FactsActive ingredient (in each caplet)
Diphenhydramine citrate 38 mg
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Nighttime sleep-aid
Pain reliever
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
- long term continuous use may increase the risk of heart attack or stroke
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
colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
Questions or comments?
1-800-719-9260
Principal Display Panel
Compare to the active ingredients in Advil® PM
# CT {insert number in package for "#"}
Ibuprofen PM
Caplets**
Ibuprofen 200mg/Pain Reliever (NSAID)
Diphenhydramine Citrate 38mg/Nighttime Sleep Aid
Tablets
Pain Reliever (NSAID)
Nighttime Sleep Aid
**Capsule Shaped Tablets
Ibuprofen PM Caplets Carton
| CVS IBUPROFEN PM
diphenhydramine citrate and ibuprofen tablet, coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA079113 | 05/01/2009 | |
| Labeler - CVS Pharmacy (062312574) |