Ibuprofen PM by CVS Pharmacy

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CVS Pharmacy
NDC Code: 69842-165

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*non-steroidal 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed
have 3 or more alcoholic drinks every day while using this product

Do not use

in children under 12 years of age
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
unless you have time for a full night’s sleep
with any other product containing diphenhydramine, even one used on skin
if you have sleeplessness without pain

Ask a doctor before use if

the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have glaucoma
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have a breathing problem such as emphysema or chronic bronchitis
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
taking any other drug
taking any other antihistamines
taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
under a doctor's care for any continuing medical illness

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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
you have symptoms of heart problem or stroke:
- chest pain
- trouble breathing
- leg swelling
- slurred speech
- weakness in one part or side of body
pain gets worse or last 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 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 childlren 12 years and over:
- take 2 capsules at bedtime
- do not take more than 2 capsules in 24 hours

Other information

each capsule contains: potassium 20 mg
read all warnings and directions before use. Keep carton.
store at 20° to 25°C (68° to 77°F)
avoid high humidity and excessive heat above 40°C (104°F)
protect from light
do not chew,crush, or dissolve capsule before swallowing

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Questions or comments?

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

Principal Display Panel

SEE NEW WARNINGS

Compare to the active ingredient in Advil® PM LIQUI-GELS®†

Ibuprofen PM

IBUPROFEN, 200 mg

DIPHENHYDRAMINE HCl, 25 mg

Pain reliever (NSAID)

Nighttime sleep-aid

SOFTGELS**

**liquid filled capsules

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor Advil® PM Liqui-Gels®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

Product Packaging

CVS HEALTH Ibuprofen PM Softgels

IBUPROFEN PM
ibuprofen, diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-165
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (IBUPROFEN)	IBUPROFEN	200 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
POLYETHYLENE GLYCOLS
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL