Ibuprofen and Diphenhydramine HCl description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Ibuprofen and Diphenhydramine HCl

Premier Value (Chain Drug Consortium, LLC)
P and L Development of New York Corporation

IBUPROFEN AND DIPHENHYDRAMINE HCL 200mg/25mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Ibuprofen and Diphenhydramine HCl 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 decrease 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 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 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 reach of children.


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

Ibuprofen and Diphenhydramine HCl 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 40ºC (104ºF)
  • 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 1-877-753-3935 Monday-Friday 9AM to 5PM EST

Principal Display Panel

†COMPARE TO THE ACTIVE INGREDIENTS IN ADVIL® PM LIQUI-GELS®

Ibuprofen PM Softgels

PAIN RELIEVER (NSAID)/NIGHTTIME SLEEP-AID

Solubilized Ibuprofen, 200 mg

Diphenhydramine HCl, 25 mg

Softgels** (**Liquid Filled Capsules)

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM Liqui-Gels®.

DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC

3301 N.W. BOCA RATON BLVD., SUITE 101

BOCA RATON, FL  33431

Rev# 09/12

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 Packaging

Ibuprofen and Diphenhydramine HCl
Premier Value Ibuprofen PM Softgels

Ibuprofen and Diphenhydramine HCl

IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-217(NDC:10888-7142)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
POLYETHYLENE GLYCOLS
POTASSIUM HYDROXIDE
water
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
BLUE (BLUE) 19 mm IBUPM OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16 in 1 BOTTLE
2 32 in 1 BOTTLE
3 NDC:68016-217-32 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090397 2013-01-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.