IBUPROFEN 200 MG AND DIPHENHYDRAMINE CITRATE 38 MG- ibuprofen, diphenhydramine citrate tablet 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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Drug Facts

Active ingredients (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 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 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
  • take 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 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 (1-800-222-1222) right away.

Directions

Other information

Inactive Ingredients

carnauba wax, corn starch, croscarmellose sodium, FD&C blue #2, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredients in Advil®PM Caplets

Ibuprofen and Diphenhydramine Citrate Tablets

200 mg/38 mg

Pain reliever (NSAID)/Nighttime sleep-aid

20 Coated caplets**

(**Capsule-shaped tablets)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Caplets.

Manufactured by:
Avéma Pharma Solutions
10400 NW 29th Terrace, Miami, FL 33172

Product Packaging

20ct FC004635 V3
IBUPROFEN 200 MG AND DIPHENHYDRAMINE CITRATE 38 MG 
ibuprofen, diphenhydramine citrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0197
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize15mm
FlavorImprint Code PL72
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0197-21 in 1 BOX04/11/2024
120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:63548-0197-88 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2024
3NDC:63548-0197-3300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21140404/11/2024
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 4/2024
Document Id: fbc47d79-348d-436e-ae3f-364d76f58e49
Set id: a7d729bf-6d7a-415a-a414-cae0ba6d0063
Version: 6
Effective Time: 20240424
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions