IBUPROFEN AND DIPHENHYDRAMINE HCL capsule, liquid filled

IBUPROFEN AND DIPHENHYDRAMINE HCL by

Drug Labeling and Warnings

IBUPROFEN AND DIPHENHYDRAMINE HCL by is a Otc medication manufactured, distributed, or labeled by Strides Shasun Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

• 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, or had a stroke.
• 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 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

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

   you have symptoms of heart problems or stroke:

            chest pain

            trouble breathing

            weakness in one part or side of body

            slurred speech

             leg swelling

    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

1. do not take more than directed
2. adults and children 12 years and over: take 2 capsules at bedtime
3. 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

Manufactured by:

Strides Shasun Limited

Bengaluru - 562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16 s label

20 s count container label

20 s count carton label

INGREDIENTS AND APPEARANCE

IBUPROFEN AND DIPHENHYDRAMINE HCL 
ibuprofen and diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64380-732
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)

Product Characteristics
Color	PURPLE (Bluish purple color)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	1007
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64380-732-14	2 in 1 CARTON	03/05/2012
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 64380-732-15	4 in 1 CARTON	03/05/2012
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 64380-732-20	24 in 1 BOX	03/05/2012
3	NDC: 64380-732-19	24 in 1 CARTON
3		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 64380-732-29	1 in 1 CARTON	12/28/2016
4		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 64380-732-12	1 in 1 CARTON	12/28/2016
5		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 64380-732-13	1 in 1 CARTON	12/28/2016
6		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 64380-732-11	1 in 1 CARTON	12/28/2016
7		120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 64380-732-18	1 in 1 CARTON	12/28/2016
8		180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Strides Shasun Limited (650738743)

Registrant - Strides Shasun Limited (650738743)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Shasun Limited		918513263	ANALYSIS(64380-732) , MANUFACTURE(64380-732)