Pain Relief Pm: Package Insert and Label Information
PAIN RELIEF PM- ibuprofen and diphenhydramine hydrochloride capsule, liquid filled
Bionpharma Inc.
Active ingredients (in each capsule)
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
Purposes
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 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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
■ 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 a doctor or 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
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
■ you have symptoms of heart problems or stroke:
■ chest pain ■ trouble breathing
■ weakness in one part or side of body
■ slurred speech ■ leg swelling
■ 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery problems in the unborn child or complications during delivery.
Keep out of 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
■ 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.
■ store at 20° to 25°C (68° to 77°F)
■ avoid 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
Questions or comments?
Call toll free 1-888-235-2466
Manufactured for:
Bionpharma
Princeton, NJ 08540
† All trademarks are property of their respective owners. † This product is not manufactured or distributed by the owners of Advil ® PM LIQUI-GELS ®.
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
R0422
L0000559
Principal Display Panel
† compare to the active ingredients in Advil ® PM Liqui-Gels ®
NDC 69452-264-22
a+health
pain relief pm
solubilized ibuprofen, 200 mg/
diphenhydramine HCl, 25 mg
pain reliever (NSAID)/
nighttime
sleep-aid
120 capsules**
**liquid-filled capsule
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| Labeler — Bionpharma Inc. (079637826) |
| Registrant — Bionpharma Inc. (079637826) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Patheon Softgels Inc. | 002193829 | manufacture (69452-264) | |
Revised: 12/2022 Bionpharma Inc.
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