IBUPROFEN AND DIPHENHYDRAMINE HCL

STRIDES ARCOLAB LIMITED
STRIDES ARCOLAB LIMITED

IBUPROFEN AND DIPHENHYDRAMINE HCL 200 mg/25 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENT
• PURPOSE
• USES
• WARNINGS
  • Allergy alert:
  • Stomach bleeding warning:
• DO NOT USE
• ASK DOCTOR BEFORE USE IF
• ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE
• WHEN USING THIS PRODUCT
• STOP USE AND ASK A DOCTOR IF
• IF PREGNANT OR BREAST FEEDING
• KEEP OUT OF REACH OF CHILDREN
• DIRECTIONS
• INACTIVE INGREDIENT
• QUESTIONS OR COMMENTS?
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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