Ibuprofen And Diphenhydramine Citrate Tablet
FDA Label NDC 55111-565

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Limited for the product Ibuprofen And Diphenhydramine Citrate (NDC 55111-565). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each caplet*), purposes, uses, allergy alert:, stomach bleeding warning:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Caplet*)

Diphenhydramine citrate USP, 38 mg

Ibuprofen USP, 200 mg (NSAID)**

* capsule-shaped tablets

**nonsteroidal anti-inflammatory drug

Purposes

Nighttime sleep-aid

Pain reliever

Uses

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

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 a nonsteroidal anti-inflammatory drug (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 You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • asthma
  • taken a diuretic
  • reached age 60 or older
  • glaucoma
  • 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
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • under a doctor’s care for any continuing medical illness
  • taking any other antihistamines
  • taking a blood thinning (anticoagulant) or steroid drug
  • 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
  • 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.
  • stomach pain or upset gets worse or lasts
  • 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.

Directions

  • do not take more than directed
  • do not take longer than 10 days, unless directed by a doctor (see WARNINGS)
  • adults and children 12 years and over: take 2 caplets at bedtime.
  • do not take more than 2 caplets in 24 hours

Other Information

  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-375-3784

Principal Display Panel

Pouch label:

DR. REDDY'S

NDC 55111-565-92

Count :2,500 Tablets

Ibuprofen Diphenhydramine Citrate Tablets 200 mg/38 mg

Batch No. :

Mfg. Date :

Repack Before :

Expiration Date :

Store at 20°-25°C (68°-77°F)

Avoid excessive heat above 40°C (104°F).

For Repackaging only.

DO NOT OPEN POUCHES UNTIL REPACKAGING

Mfd. by : Dr. Reddy's Laboratories Limited

Bachepalli - 502 325 INDIA.

Container:

Container (Container)

Container (Container)

Carton:

Carton (Carton)

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Pouch Label:

* Please review the disclaimer below.