IBUPROFEN AND DIPHENHYDRAMINE HCL- ibuprofen, diphenhydramine hcl capsule, liquid filled
P & L Development, LLC
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Drug Facts
Active ingredient (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
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:
- 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, naproxen, 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
- pain gets worse or last 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
Directions
- do not take more than directed
- adults and childlren 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° to 25°C (68° to 77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
Inactive ingredients
FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol
Principal Display Panel
†Compare to the active ingredients in Advil® PM LIQUI-GELS®
Ibuprofen and Diphenhydramine HCl
Solubilized Ibuprofen, 200 mg
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid
SOFTGELS**
(**liquid filled capsules)
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.
Manufactured by: Banner Pharmacaps Inc.
4125 Premier Drive
High Point, NC 27265
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
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.
| IBUPROFEN AND DIPHENHYDRAMINE HCL
ibuprofen, diphenhydramine hcl capsule, liquid filled |
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| Labeler - P & L Development, LLC (800014821) |
| Registrant - P & L Development, LLC (800014821) |