drug facts

drug facts
SPL v3
SPL
SPL Set ID e0f9cca2-2105-462b-ab6a-16653fb286ea
Route
oral
Published
Effective Date 2022-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ibuprofen (200 mg) diphenhydramine (25 mg)
Inactive Ingredients
fd&c blue no. 1 d&c red no. 33 gelatin polyethylene glycol, unspecified potassium hydroxide water sorbitan sorbitol hypromellose, unspecified alcohol propylene glycol povidone titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: DHI25 Shape: oval Color: blue Size: 15 mm Score: 1
Marketing Status
anda active Since 2020-05-29

Purpose

Nighttime sleep-aid Pain Reliever

Description

Diphenhydramine hydrochloride USP 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *non-steroidal anti-inflammatory drug


Medication Information

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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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

Nighttime sleep-aid

Pain Reliever

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 excessive heat above 40°C (104°F)
  • protect from light
  • Organic Impurities Test is pending
  • USP Dissolution Test is pending
  • swallow whole; do not crush, chew, or dissolve
Inactive Ingredients

D&C red #33,  FD&C blue #1, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbitan, sorbitol, titanium dioxide

Description

Diphenhydramine hydrochloride USP 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *non-steroidal anti-inflammatory drug

Principal Display Panel

Compare to the active ingredients in Advil® PM†

Ibuprofen PM

IBUPROFEN, 200 mg

DIPHENHYDRAMINE HCl, 25 mg

Pain reliever (NSAID)

Nighttime sleep-aid

SOFTGELS**

**Liquid -illed capsules

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

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

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 surgey
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain
Product Packaging
CVS HEALTH Ibuprofen PM Softgels
Questions Or Comments?

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

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
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


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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule)

Diphenhydramine hydrochloride USP 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*non-steroidal anti-inflammatory drug

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

Structured Label Content

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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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

Nighttime sleep-aid

Pain Reliever

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 (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 excessive heat above 40°C (104°F)
  • protect from light
  • Organic Impurities Test is pending
  • USP Dissolution Test is pending
  • swallow whole; do not crush, chew, or dissolve
Inactive Ingredients (Inactive ingredients)

D&C red #33,  FD&C blue #1, gelatin, hypromellose, isopropyl alcohol, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

Compare to the active ingredients in Advil® PM†

Ibuprofen PM

IBUPROFEN, 200 mg

DIPHENHYDRAMINE HCl, 25 mg

Pain reliever (NSAID)

Nighttime sleep-aid

SOFTGELS**

**Liquid -illed capsules

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

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

Do Not Use (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 surgey
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain
Product Packaging
CVS HEALTH Ibuprofen PM Softgels
Questions Or Comments? (Questions or comments?)

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

When Using This Product (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
Ask A Doctor Before Use If (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


Stop Use and Ask A Doctor If (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, (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine hydrochloride USP 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*non-steroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

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