IBUPROFEN AND DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride and ibuprofen capsule, liquid filled 
Strides Arcolab Limited

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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

USES

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

ASK DOCTOR BEFORE USE IF

ASK DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

WHEN USING THIS PRODUCT

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 Type HUMAN OTC DRUG Item Code (Source) NDC:64380-732
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE 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)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
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:64380-732-20 24 in 1 BOX
1 NDC:64380-732-19 24 in 1 CARTON
1 8 in 1 BLISTER PACK
2 NDC:64380-732-14 2 in 1 CARTON
2 8 in 1 BLISTER PACK
3 NDC:64380-732-15 4 in 1 CARTON
3 8 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200888 03/05/2012
Labeler - Strides Arcolab Limited (650738743)
Registrant - Strides Arcolab Limited (650738743)
Establishment
Name Address ID/FEI Business Operations
Strides Arcolab Limited 918513263 Analysis(64380-732) , Manufacture(64380-732)

Revised: 11/2012
Document Id: 11118c4c-bcbe-4b46-a7fb-54d66013139d
Set id: 10d52858-a55f-4053-aa77-da660556a2ad
Version: 2
Effective Time: 20121121
 
Strides Arcolab Limited