Label: DIPHENHYDRAMINE HCL AND IBUPROFEN capsule, liquid filled
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NDC Code(s):
58602-887-10,
58602-887-12,
58602-887-18,
58602-887-23, view more58602-887-30, 58602-887-73
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 19, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purposes
- Uses
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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.
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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
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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
- When using this product
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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
- you experience any of the following signs of stomach bleeding:
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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
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Inactive ingredients
D&C Red No.33, gelatin, Neelicert FD&C Blue No.1, polyethylene glycol, potassium hydroxide, povidone, purified water, sorbitol sorbitan solution.
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: TS/DRUGS/16/2014 - 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 Carton Label
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL AND IBUPROFEN
diphenhydramine hcl and ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-887 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, UNSPECIFIED (UNII: 2G86QN327L) MANNITOL (UNII: 3OWL53L36A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) POVIDONE K30 (UNII: U725QWY32X) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) 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:58602-887-73 1 in 1 CARTON 08/10/2022 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-887-10 1 in 1 CARTON 08/10/2022 2 32 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-887-12 1 in 1 CARTON 08/10/2022 3 40 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-887-18 1 in 1 CARTON 08/10/2022 4 80 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-887-23 120 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2022 6 NDC:58602-887-30 160 in 1 BOTTLE; Type 0: Not a Combination Product 08/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210676 08/10/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(58602-887) , MANUFACTURE(58602-887) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-887) , MANUFACTURE(58602-887)