Topcare Ibuprofen PM description, usages, side effects, indications, overdosage, supplying and lots more!

Topcare Ibuprofen PM

Topco Associates LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Topco Associates LLC. Ibuprofen PM Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal 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 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 non-prescription 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. (1-800-222-1222)

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

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

SEE NEW WARNINGS INFORMATION

CAPLETS

Ibuprofen PM

IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLETS, 200 mg/38mg

Pain Reliever (NSAID)

Nighttime Sleep-Aid

actual size

COMPARE TO ADVIL® PM active ingredients

40 COATED CAPLETS†

†CAPSULE-SHAPED TABLETS

Topcare Ibuprofen PM

diphenhydramine citrate and ibuprofen TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-050
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE 38 mg
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE (TYPE H)
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
talc
titanium dioxide
FERROSOFERRIC OXIDE
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
BLUE 15 mm L050 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 80 in 1 BOTTLE
2 40 in 1 BOTTLE
3 20 in 1 BOTTLE
4 NDC:36800-050-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079113 2009-02-18


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