Label: IBUPROFEN AND DIPHENHYDRAMINE HCL- ibuprofen, diphenhydramine hcl capsule, liquid filled
- NDC Code(s): 49035-065-40
- Packager: EQUATE (Wal-Mart Stores, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
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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
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Advil® PM Liqui-Gels® Active Ingredients**
Ibuprofen PM Softgels
Ibuprofen 200 mg
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID) / Nighttime Sleep-Aid
NIGHTTIME
SOFTGELS**
(**liquid filled capsules)
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DO NOT USE IF TAMPER-EVIDENT: SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
DISTRIBUTED: BY Wal-Mart Stores, Inc.,
Bentonville, AR 72716
- Product Packaging
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INGREDIENTS AND APPEARANCE
IBUPROFEN AND DIPHENHYDRAMINE HCL
ibuprofen, diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-065 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color blue Score no score Shape OVAL Size 15mm Flavor Imprint Code IBUPM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-065-40 1 in 1 BOX 12/31/2015 04/26/2024 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090397 12/31/2015 04/26/2024 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
