Skip to main content

Ibuprofen and Diphenhydramine

Package insert / prescribing information
Generic name: Ibuprofen and Diphenhydramine citrate
Dosage form: tablet
Drug class: Analgesic combinations

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

DRUG FACTS

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

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 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.

DIRECTIONS

  • do not take more than directed
  • 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?

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.

PRINCIPAL DISPLAY PANEL

Container:

Container carton

Ibuprofen and Diphenhydramine CITRATE
Ibuprofen and Diphenhydramine citrate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-565
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 200 mg
Diphenhydramine Citrate (Diphenhydramine) Diphenhydramine Citrate 38 mg
Inactive Ingredients
Ingredient Name Strength
carnauba wax
STARCH, CORN
Silicon Dioxide
croscarmellose sodium
FD&C blue no. 2
CELLULOSE, MICROCRYSTALLINE
hypromelloses
polydextrose
polyethylene glycol 400
sodium lauryl sulfate
stearic acid
titanium dioxide
Product Characteristics
Color BLUE (blue) Score no score
Shape CAPSULE (slightly glossy smooth blue film coated) Size 15mm
Flavor Imprint Code RDY;565
Contains
Packaging
# Item Code Package Description
1 NDC:55111-565-14 1 BOTTLE in 1 CARTON
1 20 TABLET in 1 BOTTLE
2 NDC:55111-565-30 1 BOTTLE in 1 CARTON
2 30 TABLET in 1 BOTTLE
3 NDC:55111-565-40 1 BOTTLE in 1 CARTON
3 40 TABLET in 1 BOTTLE
4 NDC:55111-565-80 1 BOTTLE in 1 CARTON
4 80 TABLET in 1 BOTTLE
5 NDC:55111-565-90 1 BOTTLE in 1 CARTON
5 90 TABLET in 1 BOTTLE
6 NDC:55111-565-18 1 BOTTLE in 1 CARTON
6 180 TABLET in 1 BOTTLE
7 NDC:55111-565-05 1 BOTTLE in 1 CARTON
7 500 TABLET in 1 BOTTLE
8 NDC:55111-565-92 2500 TABLET in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090619 01/31/2010
Labeler - Dr. Reddy's Laboratories Limited (650562841)
Dr. Reddy's Laboratories Limited