Label: ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated
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NDC Code(s):
0573-0164-04,
0573-0164-05,
0573-0164-08,
0573-0164-09, view more0573-0164-12, 0573-0164-14, 0573-0164-20, 0573-0164-21, 0573-0164-30, 0573-0164-32, 0573-0164-33, 0573-0164-40, 0573-0164-41, 0573-0164-43, 0573-0164-44, 0573-0164-45, 0573-0164-46, 0573-0164-49, 0573-0164-55, 0573-0164-65, 0573-0164-91
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 8, 2024
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 caplet)
- 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:
- 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
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [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
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
- 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
- stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you have a breathing problem such as emphysema or chronic bronchitis
- you have glaucoma
- 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
- under a doctor's care for any continuing medical illness
- taking any other antihistamines
- 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
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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.
- redness or swelling is present in the painful area
- any new symptoms appear
- Directions
- Other ingredients
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Inactive ingredients
calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
- Questions or Comments?
- Additional Information
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ADVIL PM
diphenhydramine citrate and ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0164 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE (UNII: 776XM7047L) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (blue) Score no score Shape OVAL Size 15mm Flavor Imprint Code Advil;PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0164-33 1 in 1 CARTON 12/21/2005 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0164-04 4 in 1 POUCH; Type 0: Not a Combination Product 12/21/2005 3 NDC:0573-0164-20 1 in 1 CARTON 12/21/2005 3 20 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0573-0164-30 1 in 1 CARTON 12/21/2005 4 40 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0573-0164-40 1 in 1 CARTON 12/21/2005 5 80 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0573-0164-43 1 in 1 CARTON 12/21/2005 6 120 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0164-45 1 in 1 CARTON 12/21/2005 7 180 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0573-0164-32 1 in 1 CARTON 12/21/2005 8 50 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:0573-0164-41 1 in 1 CARTON 12/21/2005 9 100 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:0573-0164-91 3000 in 1 BOX 12/21/2005 10 2 in 1 POUCH; Type 0: Not a Combination Product 11 NDC:0573-0164-05 2 in 1 CARTON 12/21/2005 11 2 in 1 BOTTLE; Type 0: Not a Combination Product 12 NDC:0573-0164-55 50 in 1 TRAY 12/21/2005 12 2 in 1 POUCH; Type 0: Not a Combination Product 13 NDC:0573-0164-21 1 in 1 CARTON 12/21/2005 13 30 in 1 BOTTLE; Type 0: Not a Combination Product 14 NDC:0573-0164-44 1 in 1 CARTON 12/21/2005 14 140 in 1 BOTTLE; Type 0: Not a Combination Product 15 NDC:0573-0164-14 2 in 1 CARTON 12/21/2005 15 2 in 1 POUCH; Type 0: Not a Combination Product 16 NDC:0573-0164-12 6 in 1 CARTON 12/21/2005 16 2 in 1 POUCH; Type 0: Not a Combination Product 17 NDC:0573-0164-49 1 in 1 CARTON 12/21/2005 17 200 in 1 BOTTLE; Type 0: Not a Combination Product 18 NDC:0573-0164-46 1 in 1 CARTON 12/21/2005 18 180 in 1 BOTTLE; Type 0: Not a Combination Product 19 NDC:0573-0164-65 120 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2016 20 NDC:0573-0164-08 1 in 1 PACKAGE 03/17/2017 20 8 in 1 VIAL; Type 0: Not a Combination Product 21 NDC:0573-0164-09 8 in 1 VIAL; Type 0: Not a Combination Product 03/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021394 12/21/2005 Labeler - Haleon US Holdings LLC (079944263)