Your browser does not support JavaScript! IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]
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IBUPROFEN AND DIPHENHYDRAMINE HCL capsule, liquid filled
[Strides Arcolab Limited]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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

  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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16s label

16s label

IBUPROFEN AND DIPHENHYDRAMINE HCL 
ibuprofen and diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64380-732
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE25 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 
SHELLAC 
TITANIUM DIOXIDE 
BUTYL ALCOHOL 
LECITHIN, SOYBEAN 
POLYETHYLENE GLYCOL 600 
Product Characteristics
ColorPURPLE (Bluish purple color) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 1007
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64380-732-2024 in 1 BOX
1NDC:64380-732-1924 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:64380-732-142 in 1 CARTON
28 in 1 BLISTER PACK
3NDC:64380-732-154 in 1 CARTON
38 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20088803/05/2012
Labeler - Strides Arcolab Limited (650738743)
Registrant - Strides Arcolab Limited (650738743)
Establishment
NameAddressID/FEIBusiness Operations
Strides Arcolab Limited 918513263Analysis(64380-732), Manufacture(64380-732)

Revised: 11/2012
 
Strides Arcolab Limited

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