Label: ADVIL PM- diphenhydramine hcl, ibuprofen capsule, liquid filled
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NDC Code(s):
0573-0148-06,
0573-0148-07,
0573-0167-10,
0573-0167-18, view more0573-0167-19, 0573-0167-20, 0573-0167-21, 0573-0167-25, 0573-0167-26, 0573-0167-42, 0573-0167-43, 0573-0167-44, 0573-0167-55, 0573-0167-56
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 15, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purposes
- Uses
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Warnings
Allergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
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.
Do not use
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- unless you have time for a full night's sleep
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- in children under 12 years of age
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- right before or after heart surgery
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- with any other product containing diphenhydramine, even one used on skin
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- if you have sleeplessness without pain
Ask a doctor before use if
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- stomach bleeding warning applies to you
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke.
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- you are taking a diuretic
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- you have a breathing problem such as emphysema or chronic bronchitis
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- you have glaucoma
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- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers, or any other sleep-aid
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- under a doctor's care for any continuing medical illness
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- taking any other antihistamines
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
When using this product
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- drowsiness will occur
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- avoid alcoholic drinks
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- do not drive a motor vehicle or operate machinery
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- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- pain gets worse or lasts more than 10 days
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- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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- redness or swelling is present in the painful area
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- any new symptoms appear
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
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Additional Information
Do Not Use if seal under bottle cap imprinted with
“SEALED for YOUR PROTECTION” is broken or missing.For most recent product information, visit www.Advil.com
Dist. by: Haleon, Warren, NJ 07059
Trademarks owned or licensed to the Haleon group of companies.
© 2024 Haleon group of companies or its licensor.
Patents: www.productpats.com
LIQUI-GELS is a trademark or registered trademark
of Catalent Pharma Solutions.
- PRINCIPAL DISPLAY PANEL (Advil PM Liqui-Gels)
- Principal Display Panel (Advil PM Liqui-Gels Minis)
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INGREDIENTS AND APPEARANCE
ADVIL PM
diphenhydramine hcl, ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0167 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE (Clear blue) Score no score Shape OVAL (Oval liqui-gel) Size 15mm Flavor Imprint Code Advil;PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0167-10 16 in 1 CARTON 12/20/2005 12/07/2017 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0573-0167-20 32 in 1 CARTON 12/20/2005 12/07/2017 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0573-0167-21 40 in 1 CARTON 12/20/2005 12/07/2017 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0573-0167-25 1 in 1 CARTON 12/20/2005 4 20 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0573-0167-43 1 in 1 CARTON 12/20/2005 5 40 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0573-0167-55 1 in 1 CARTON 12/20/2005 6 80 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0167-18 24 in 1 CARTON 12/20/2005 12/07/2017 7 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:0573-0167-19 24 in 1 CARTON 12/20/2005 12/07/2017 8 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 9 NDC:0573-0167-26 1 in 1 CARTON 12/20/2005 9 30 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:0573-0167-42 40 in 1 CARTON 12/20/2005 12/07/2017 10 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 11 NDC:0573-0167-44 1 in 1 CARTON 12/20/2005 11 50 in 1 BOTTLE; Type 0: Not a Combination Product 12 NDC:0573-0167-56 1 in 1 CARTON 12/20/2005 12 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021393 12/20/2005 ADVIL PM
diphenhydramine hcl, ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0148 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE (Clear blue) Score no score Shape OVAL (Oval liqui-gel) Size 13mm Flavor Imprint Code Advil;PM;Minis Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0148-06 1 in 1 CARTON 01/15/2025 1 40 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0148-07 1 in 1 CARTON 01/15/2025 2 80 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021393 01/15/2025 Labeler - Haleon US Holdings LLC (079944263)