DIPHENHYDRAMINE HCL AND IBUPROFEN capsule, liquid filled

Diphenhydramine HCl and Ibuprofen by

Drug Labeling and Warnings

Diphenhydramine HCl and Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients
(in each capsule)

Diphenhydramine hydrochloride USP 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
*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 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, 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 a 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 overdose, get medical help or contact a Poison Control Center right away. [1-800-222-1222]

Directions

• do not take more than directed
• adults and children 12 years and over: take 2 capsules at bedtime
• 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° to 25°C (68° to 77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light
• Organic Impurities Test is Pending
• USP Dissolution Test is pending

Inactive ingredients

D&C Red No.33, gelatin, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbital sorbitan solution, titanium dioxide.

Questions or comments?

Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

Code No.: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Label

NDC: 58602-814-73
Diphenhydramine
HCl and Ibuprofen
Capsules USP
25 mg/200 mg
Nighttime Sleep-Aid/
Pain Reliever (NSAID)
20 Liquid Filled Capsules
READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION
AUROHEALTH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg/200 mg (20 Liquid-Filled Capsules) Bottle Carton Label

NDC: 58602-814-73
Diphenhydramine HCl
and Ibuprofen Capsules USP
25 mg/200 mg
Nighttime Sleep-Aid/Pain Reliever (NSAID)
AUROHEALTH                     20 Liquid Filled Capsules

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-814
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
1,4-SORBITAN (UNII: AV0YTZ4E6J)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MANNITOL (UNII: 3OWL53L36A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	DHI25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-814-73	1 in 1 CARTON	02/14/2019
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58602-814-10	1 in 1 CARTON	02/14/2019
2		32 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58602-814-12	1 in 1 CARTON	02/14/2019
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 58602-814-18	1 in 1 CARTON	02/14/2019
4		80 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 58602-814-23	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2019
6	NDC: 58602-814-30	160 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210676	02/14/2019

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650844777	ANALYSIS(58602-814) , MANUFACTURE(58602-814)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-814) , MANUFACTURE(58602-814)