NDC | 63941-166-16, 63941-166-32 |
Set ID | 715077c8-dad5-4dfd-b5c6-6e33545f322b |
Category | HUMAN OTC DRUG LABEL |
Packager | Valu Merchandisers Company (Best Choice) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA090397 |
- Active Ingredients (in each capsule)
- Purpose
- Uses
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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:
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- take other drugs containing prescription or nonprescription NSAIDS [aspirin, ibuprofen, naproxin, or others]
- take more or for a longer time than directed.
- have 3 or more alcoholic drinks every day while using this product
Do not use
- in children under 12 years of age
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
- unless you have time for a full night’s sleep
- with any other product containing diphenhydramine , even one used on skin
- if you have sleeplessness without pain
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have glaucoma
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers.
- you have a breathing problem such as emphysema or chronic bronchitis
- you have 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
- taking any other antihistamines
- taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
- under a doctor's care for any continuing medical illness
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
-
have bloody or black stools
-
vomit blood
-
have stomach pain that does not get better
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pain gets worse or last more than 10 days
-
sleepnessness 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.
-
- Directions
- Inactive Ingredients
- Questions or comments?
-
Principal Display Panel
†Compare to the active ingredients in Advil® PM LIQUI-GELS®
IBUPROFEN PM SOFTGELS
Solubilized Ibuprofen, 200 mg
Diphenhydramine HCl, 25 mg
PAIN RELIEVER (NSAID)/ NIGHTTIME SLEEP-AID
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- Product Label
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INGREDIENTS AND APPEARANCE
IBUPROFEN PM
ibuprofen and diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-166 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE (BLUE) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code IBUPM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-166-32 4 in 1 CARTON 1 8 in 1 BLISTER PACK 2 NDC:63941-166-16 2 in 1 CARTON 2 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090397 06/10/2011 Labeler - Valu Merchandisers Company (Best Choice) (868703513) Registrant - P and L Development of New York Corporation (800014821)