Tuesday, October 25, 2016

Advil PM



diphenhydramine citrate, ibuprofen

Dosage Form: tablet, coated
Advil PM (diphenhydramine citrate and ibuprofen)

DRUG FACTS



ACTIVE INGREDIENTS (IN EACH CAPLET)


Diphenhydramine citrate 38 mg


Ibuprofen 200 mg (NSAID)*


*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


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, or asthma

  • 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

  • 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

    • vomit blood

    • have bloody or black stools

    • 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 the 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 caplets at bedtime

  • do not take more than 2 caplets in 24 hours


OTHER INFORMATION


  • read all warnings and directions before use. Keep carton.

  • store at 20-25°C (68-77°F)

  • avoid excessive heat above 40°C (104°F)


INACTIVE INGREDIENTS


calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide



QUESTIONS OR COMMENTS?


Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL



PRODUCT PACKAGING


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.


Advil PM


Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg


Pain Reliever (NSAID) / Nighttime Sleep-Aid


40 Coated Caplets*


*Capsule-Shaped Tablets


See new warnings information


READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.


Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.


Wyeth


For most recent product information, visit www.Advil.com.


Wyeth Consumer Healthcare, Madison, NJ 07940 USA ©2009 Wyeth


Appearance of the blue Advil PM caplet is a trademark of Wyeth Consumer Healthcare


U.S. Patent Pending










Advil PM 
diphenhydramine citrate, ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0164
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine citrate (diphenhydramine )diphenhydramine citrate38 mg
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBLUE (blue)Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeAdvil;PM
Contains      


























































































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0164-331 BOTTLE In 1 CARTONcontains a BOTTLE
150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-33)
20573-0164-044 TABLET In 1 POUCHNone
30573-0164-201 BOTTLE In 1 CARTONcontains a BOTTLE
320 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-20)
40573-0164-301 BOTTLE In 1 CARTONcontains a BOTTLE
440 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-30)
50573-0164-401 BOTTLE In 1 CARTONcontains a BOTTLE
580 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-40)
60573-0164-431 BOTTLE In 1 CARTONcontains a BOTTLE
6120 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-43)
70573-0164-451 BOTTLE In 1 CARTONcontains a BOTTLE
7180 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-45)
80573-0164-321 BOTTLE In 1 CARTONcontains a BOTTLE
850 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-32)
90573-0164-411 BOTTLE In 1 CARTONcontains a BOTTLE
9100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-41)
100573-0164-913000 POUCH In 1 BOXcontains a POUCH
102 TABLET In 1 POUCHThis package is contained within the BOX (0573-0164-91)
110573-0164-052 POUCH In 1 CARTONcontains a BOTTLE
112 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0164-05)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02139412/21/2005


Labeler - Pfizer Consumer Healthcare (828831730)









Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975MANUFACTURE, ANALYSIS
Revised: 06/2010Pfizer Consumer Healthcare




More Advil PM resources


  • Advil PM Side Effects (in more detail)
  • Advil PM Use in Pregnancy & Breastfeeding
  • Drug Images
  • Advil PM Drug Interactions
  • Advil PM Support Group
  • 0 Reviews for Advil PM - Add your own review/rating


  • Advil PM MedFacts Consumer Leaflet (Wolters Kluwer)



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