IBUPROFEN PM- ibuprofen, diphenhydramine hcl capsule, liquid filled 
TOP CARE (Topco Associates LLC)

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Drug Facts

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

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

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

Other information

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

Diphenhydramine HCI 25 mg, Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

TOPCARE Ibuprofen 200 mg Softgels

IBUPROFEN PM 
ibuprofen, diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-756
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScoreno score
ShapeOVALSize16mm
FlavorImprint Code 1007
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-756-401 in 1 BOX07/31/2018
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20088807/31/2018
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 11/2022
Document Id: c0457da6-52b2-4775-9282-ab6d09a9fb37
Set id: 7af82ca5-ea36-4b72-88b8-0fe68348d269
Version: 3
Effective Time: 20221128
 
TOP CARE (Topco Associates LLC)