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IBUPROFEN AND DIPHENHYDRAMINE HCL

Medically reviewed on March 5, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg, IBUPROFEN 200mg
Labeler: Strides Shasun Limited
NDC Code: 64380-732

IBUPROFEN AND DIPHENHYDRAMINE HCL 200 mg/25 mg

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

IBUPROFEN AND DIPHENHYDRAMINE HCL 
ibuprofen and diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64380-732
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
GELATIN 
MEDIUM-CHAIN TRIGLYCERIDES 
POTASSIUM HYDROXIDE 
WATER 
SORBITAN 
SORBITOL 
POLYETHYLENE GLYCOL 600 
Product Characteristics
ColorPURPLE (Bluish purple color) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code1007
Contains    
Packaging
#Item CodePackage Description
1NDC:64380-732-142 BLISTER PACK in 1 CARTON
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:64380-732-154 BLISTER PACK in 1 CARTON
28 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:64380-732-2024 CARTON in 1 BOX
3NDC:64380-732-1924 BLISTER PACK in 1 CARTON
38 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
4NDC:64380-732-291 BOTTLE, PLASTIC in 1 CARTON
420 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
5NDC:64380-732-121 BOTTLE, PLASTIC in 1 CARTON
540 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
6NDC:64380-732-131 BOTTLE, PLASTIC in 1 CARTON
680 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
7NDC:64380-732-111 BOTTLE, PLASTIC in 1 CARTON
7120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
8NDC:64380-732-181 BOTTLE, PLASTIC in 1 CARTON
8180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20088803/05/2012
Labeler - Strides Shasun Limited (650738743)
Registrant - Strides Shasun Limited (650738743)
Establishment
NameAddressID/FEIOperations
Strides Shasun Limited918513263ANALYSIS(64380-732), MANUFACTURE(64380-732)

 
Strides Shasun Limited

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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