CARE ONE IBUPROFEN PM - diphenhydramine citrate and ibuprofen tablet 
American Sales Company

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Care One Ibuprofen PM Drug Facts

Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

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 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
• long term continuous use may increase the risk of heart attack or stroke

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

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments? 

1-800-719-9260

Principal Display Panel

Compare to the active ingredients in Advil® PM Caplets

Ibuprofen PM

Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg

Pain Reliever (NSAID)/Nighttime Sleep-Aid

**Capsule-Shaped Tablets

CARE ONE IBUPROFEN PM  diphenhydramine citrate and ibuprofen   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41520-050 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE 38 mg IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE Score no score Shape CAPSULE (tablet) Size 15mm Flavor Imprint Code L050 Contains

Packaging # NDC Package Description Multilevel Packaging 1 41520-050-27 1 BOTTLE In 1 CARTON contains a BOTTLE 1 80 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-050-27) 2 41520-050-48 1 BOTTLE In 1 CARTON contains a BOTTLE 2 180 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-050-48) 3 41520-050-58 1 BOTTLE In 1 CARTON contains a BOTTLE 3 40 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-050-58) 4 41520-050-71 1 BOTTLE In 1 CARTON contains a BOTTLE 4 50 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-050-71) 5 41520-050-60 1 BOTTLE In 1 CARTON contains a BOTTLE 5 20 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-050-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079113	06/08/2009

Labeler - American Sales Company (809183973)

Revised: 06/2009American Sales Company