ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED- advil pm tablet, coated
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated by
Drug Labeling and Warnings
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Drug Facts
- Active Ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Allergy alert
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:
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
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
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
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
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
If pregnant or breast-feeding,
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Directions
- Other Information
-
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?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
PRINCIPAL DISPLAY PANEL
Advil PM
Ibuprofen, 200 mg /
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-AidCoated Caplets*
* Capsule-Shaped Tablets
- For relief of occasional sleeplessness when associated with minor aches and pains
- Helps you fall asleep and stay asleep
See full Drug Facts information
on the side and back of this dispenser
30 PACKETS OF 2 COATED CAPLETS*
*Capsule-Shaped Tablets
- CVP 4 Count Carton
-
INGREDIENTS AND APPEARANCE
ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED
advil pm tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 29485-7937 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color 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: 29485-7937-6 3 in 1 BLISTER PACK 02/06/2017 11/07/2025 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021394 02/06/2017 11/07/2025 ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED
advil pm tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 29485-7088 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color 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: 29485-7088-4 2 in 1 BLISTER PACK 08/31/2011 01/23/2026 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021394 08/31/2011 01/23/2026 ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED
advil pm tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 29485-7008 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color 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: 29485-7008-3 30 in 1 BOX 04/24/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021394 04/24/2017 ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED
advil pm tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 29485-6644 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) STEARIC ACID (UNII: 4ELV7Z65AP) CALCIUM STEARATE (UNII: 776XM7047L) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color 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: 29485-6644-2 1 in 1 BLISTER PACK 03/11/2010 11/16/2025 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021394 03/11/2010 11/16/2025 ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED
advil pm tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 29485-6533 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CALCIUM STEARATE (UNII: 776XM7047L) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Product Characteristics Color 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: 29485-6533-4 2 in 1 CARTON 08/25/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021394 08/25/2017 Labeler - Lil Drug Store Products, Inc (093103646)
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