IBUPROFEN AND DIPHENHYDRAMINE HCL description, usages, side effects, indications, overdosage, supplying and lots more!

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IBUPROFEN AND DIPHENHYDRAMINE HCL

STRIDES ARCOLAB LIMITED
STRIDES ARCOLAB LIMITED

IBUPROFEN AND DIPHENHYDRAMINE HCL 200 mg/25 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredient(s)                                                                  

(In each capsule)

Diphenhydramine hydrochloride 25 mg

Solubilized Ibuprofen equal to Ibuprofen 200 mg (NSAID)* (Present as the free acid and potassium salt)

*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 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 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 DOCTOR/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 REACH OF CHILDREN

In case of medical 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 capsules at bedtime
  • do not take more than 2 capsules in 24 hours

OTHER INFORMATION

• Each capsule contains: potassium 20 mg

• 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)

• Protect from light

INACTIVE INGREDIENT

Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.

Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.

QUESTIONS OR COMMENTS?

Call at 1877 244 9825

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IBUPROFEN AND DIPHENHYDRAMINE HCL
16s label

IBUPROFEN AND DIPHENHYDRAMINE HCL

IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64380-732
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 33
FD&C BLUE NO. 1
GELATIN
MEDIUM-CHAIN TRIGLYCERIDES
POTASSIUM HYDROXIDE
water
SORBITAN
sorbitol
SHELLAC
titanium dioxide
BUTYL ALCOHOL
LECITHIN, SOYBEAN
POLYETHYLENE GLYCOL 600

Product Characteristics

Color Size Imprint Code Shape
PURPLE (Bluish purple color) 16 mm 1007 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 8 in 1 BLISTER PACK
4 NDC:64380-732-15 4 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200888 2012-03-05


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Be sure to consult your doctor before taking any medication!
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