Diphenhydramine Hcl And Ibuprofen Capsules Usp 25 Mg/200 Mg

Diphenhydramine Hcl And Ibuprofen Capsules Usp 25 Mg/200 Mg
SPL v5
SPL
SPL Set ID a656f8b0-8cb4-4802-b8d3-7b95c0265d56
Route
ORAL
Published
Effective Date 2022-02-24
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Ibuprofen (200 mg)
Inactive Ingredients
1,4-sorbitan D&c Red No. 33 Gelatin Type B Bovine (160 Bloom) Hypromellose 2910 (3 Mpa.s) Isopropyl Alcohol Mannitol Fd&c Blue No. 1 Polyethylene Glycol 600 Potassium Hydroxide Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: DHI25 Shape: oval Color: blue Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2019-02-14

Description

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

Purpose

Nighttime sleep-aid Pain reliever


Medication Information

Purpose

Nighttime sleep-aid Pain reliever

Description

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

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
Purposes

Nighttime sleep-aid

Pain reliever

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.

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
  • Meets USP dissolution test 2


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
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

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, sorbitol 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

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code No.: TS/DRUGS/22/2009

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
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
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 at 20 weeks or later in 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]

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
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




Structured Label Content

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
Purposes

Nighttime sleep-aid

Pain reliever

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.

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
  • Meets USP dissolution test 2


Do Not Use (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
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

Inactive Ingredients (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, sorbitol 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

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code No.: TS/DRUGS/22/2009

When Using This Product (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
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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. (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]

Ask A Doctor Or Pharmacist Before Use If You Are (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
Package Label Principal Display Panel 25 Mg/200 Mg (20 Liquid Filled Capsules) Bottle Label (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 (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




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