Ibuprofen PM by Freds Inc
Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Freds Inc
NDC Code: 55315-165
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
- for relief of occasional sleeplessness when associated with minor aches and pains
- helps you fall asleep and stay asleep
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- facial swelling
- asthma (wheezing)
- skin reddening
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
- 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
- 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
- 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
- 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.
- you experience any of the following signs of stomach bleeding:
have bloody or black stools
have stomach pain that does not get better
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.
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.
In case of overdose, get medical help or contact a poison control center right away
- 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
- 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 excessively heat above 40o C (104o F)
- protect from light.
FD&C Blue #1, FD&C Red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan,sorbitol
call 1-877-753-3935 Monday- Friday 9AM-5PM EST
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
(**Liquid Filled Capsules)
†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
ibuprofen and diphenhydramine hcl capsule, liquid filled
|Labeler - Freds Inc (005866116)|
|Registrant - P and L Development of New York Corporation (800014821)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.