IBUPROFEN PM- ibuprofen, diphenhydramine hcl capsule, liquid filled

Ibuprofen PM by

Drug Labeling and Warnings

Ibuprofen PM by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Purpose

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:

• 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

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

• 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,  asthma or had a stroke 
• 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

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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • leg swelling
  • slurred speech
  • weakness in one part or side of body
• 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

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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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
• store at 20º to 25ºC (68º to 77ºF) 
• avoid excessive heat above 40°C (104°F)
• protect from light
• swallow whole: do not crush, chew, or dissolve
• read all warnings and directions before use. Keep carton.

Inactive ingredients

D&C red #33, FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

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

NIGHTTIME

Ibuprofen PM  Capsules

PAIN RELIEVER (NSAID) NIGHTTIME SLEEP-AID

IBUPROFEN & DIPHENHYDRAMINE HCI 200 mg/25mg

SOFTGELS**

**Liquid-Filled Capsules

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO PLVA0318

topcare@topco.com

www.topcarebrand.com

Product Packaging

TOPCARE Ibuprofen 200 mg Softgels

INGREDIENTS AND APPEARANCE

IBUPROFEN PM 
ibuprofen, diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-756
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	1007
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-756-40	1 in 1 BOX	07/31/2018
1		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200888	07/31/2018

Labeler - TOP CARE (Topco Associates LLC) (006935977)