IBUPROFEN PM - ibuprofen and diphenhydramine citrate tablet, coated 
KROGER COMPANY

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Diphenhydramine Citrate and Ibuprofen Tablets USP 38 mg/200 mg

Drug Facts

Active ingredients
(in each caplet)

Diphenhydramine citrate USP 38 mg
Ibuprofen USP 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purposes

Nighttime sleep-aid
Pain reliever

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:


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

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


Ask a doctor before use if


Ask a doctor or pharmacist before use if you are


When using this product


Stop use and ask a doctor if


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 (1-800-222-1222) right away.

Directions

Other information


Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and titanium dioxide.

Questions or comments?

Call 1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (80 Coated Caplets) Bottle Label

Kroger®
health

NDC 30142-278-80

Ibuprofen PM
Ibuprofen and
Diphenhydramine Citrate
Tablets
200 mg/38 mg

PAIN RELIEVER (NSAID)* /        80 COATED CAPLETS
NIGHTTIME SLEEP-AID              CAPSULE-SHAPED TABLETS




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (20 Coated Caplets) Bottle Label



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (80 Coated Caplets) Bottle Carton Label

Kroger®
health

NDC 30142-278-80

COMPARE TO ACTIVE
INGREDIENTS IN ADVIL® PM CAPLETS^

Ibuprofen  PM
Ibuprofen and Diphenhydramine Citrate
Tablets 200 mg/38 mg

PAIN RELIEVER (NSAID)* /        80 COATED CAPLETS 
NIGHTTIME SLEEP-AID              CAPSULE-SHAPED TABLETS

200 
ACTUAL SIZE   


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (20 Coated Caplets) Bottle Carton Label

IBUPROFEN PM 
ibuprofen and diphenhydramine citrate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-278
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
PALMITIC ACID (UNII: 2V16EO95H1)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code DI;200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-278-801 in 1 CARTON05/07/2024
180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21620405/07/2024
Labeler - KROGER COMPANY (006999528)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777ANALYSIS(30142-278) , MANUFACTURE(30142-278)

Revised: 5/2024
Document Id: be255349-0c83-449c-9f9f-9a66603dae5d
Set id: 15e649c4-d75f-e8c1-e063-6294a90a7747
Version: 2
Effective Time: 20240521
 
KROGER COMPANY