Ibuprofen and Diphenhydramine Citrate

Dr. Reddy's Laboratories Limited

Ibuprofen and Diphenhydramine Citrate Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENTS (IN EACH CAPLET*)
• PURPOSES
• USES
• WARNINGS
  • Allergy alert:
  • Stomach bleeding warning:
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or 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 the reach of children.
• DIRECTIONS
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS OR COMMENTS?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET*)

Diphenhydramine citrate USP, 38 mg

Ibuprofen USP, 200 mg (NSAID)**

* capsule-shaped tablets

**nonsteroidal anti-inflammatory drug

PURPOSES

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 a nonsteroidal anti-inflammatory drug (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 an NSAID [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 you have

• a breathing problem such as emphysema or chronic bronchitis
• problems or serious side effects from taking pain relievers or fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• asthma
• taken a diuretic
• reached age 60 or older
• glaucoma
• 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 containing an NSAID (prescription or nonprescription)
• under a doctor’s care for any continuing medical illness
• taking any other antihistamines
• taking a blood thinning (anticoagulant) or steroid drug
• 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
• 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.
• stomach pain or upset gets worse or lasts
• 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.

DIRECTIONS

• do not take more than directed
• do not take longer than 10 days, unless directed by a doctor (see WARNINGS)
• 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

carnauba wax, corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2, hypromelllose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, pregelatinized starch, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS OR COMMENTS?

Call 1-888-375-3784

Do Not Use if foil seal under bottle cap imprinted with“SEALED for YOUR PROTECTION”  is broken or missing.

Manufactured for:Dr. Reddy’s Laboratories Limited Bachepalli – 502 325 INDIA.

PRINCIPAL DISPLAY PANEL

Pouch label:

DR. REDDY'S

NDC 55111-565-92

Count :2,500 Tablets

Ibuprofen Diphenhydramine Citrate Tablets 200 mg/38 mg

Batch No. :

Mfg. Date :

Repack Before :

Expiration Date :

Store at 20°-25°C (68°-77°F)

Avoid excessive heat above 40°C (104°F).

For Repackaging only.

DO NOT OPEN POUCHES UNTIL REPACKAGING

Mfd. by : Dr. Reddy's Laboratories Limited

Bachepalli - 502 325 INDIA.

Container:

Carton:

Pouch Label: