IBUPROFEN AND DIPHENHYDRAMINE CITRATE- ibuprofen and diphenhydramine citrate tablet 
Dr. Reddy's Laboratories Limited


Ibuprofen and Diphenhydramine Citrate Tablets



Diphenhydramine citrate USP, 38 mg

Ibuprofen USP, 200 mg (NSAID)**

* capsule-shaped tablets

**nonsteroidal anti-inflammatory drug


Nighttime sleep-aid

Pain reliever



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 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 an NSAID [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

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, or asthma
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.




carnauba wax, corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2, hypromelllose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, pregelatinized starch, sodium lauryl sulfate, stearic acid, titanium dioxide


Call 1-888-375-3784

Do Not Use if foil seal under bottle cap imprinted with“SEALED for YOUR PROTECTION”  is broken or missing.

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA.




Container carton


ibuprofen and diphenhydramine citrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-565
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)  
croscarmellose sodium (UNII: M28OL1HH48)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
hypromelloses (UNII: 3NXW29V3WO)  
polydextrose (UNII: VH2XOU12IE)  
polyethylene glycol 400 (UNII: B697894SGQ)  
sodium lauryl sulfate (UNII: 368GB5141J)  
stearic acid (UNII: 4ELV7Z65AP)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (blue) Scoreno score
ShapeCAPSULE (slightly glossy smooth blue film coated) Size15mm
FlavorImprint Code RDY;565
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-565-141 in 1 CARTON01/31/2010
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-565-301 in 1 CARTON01/31/2010
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-565-401 in 1 CARTON01/31/2010
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-565-801 in 1 CARTON01/31/2010
480 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-565-901 in 1 CARTON01/31/2010
590 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-565-181 in 1 CARTON01/31/2010
6180 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-565-051 in 1 CARTON01/31/2010
7500 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:55111-565-922500 in 1 POUCH; Type 0: Not a Combination Product01/31/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Dr. Reddy's Laboratories Limited (650562841)

Revised: 12/2018
Document Id: d2953b94-9244-2c86-ac0c-7610dd1e7963
Set id: 42c06daf-541a-7721-b875-ea18364501a4
Version: 3
Effective Time: 20181205
Dr. Reddy's Laboratories Limited