Label: EQUALINE NAPROXEN SODIUM PM- diphenhydramine hydrochloride, naproxen sodium tablet, film coated
- NDC Code(s): 41163-593-58, 41163-593-71
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 7, 2023
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- Active ingredients (in each caplet)
- Purposes
- Uses
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Warnings
Allergy alert: Naproxen sodium 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 serious condition
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- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
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- taking any other antihistamines
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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
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- you have difficulty swallowing
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- it feels like the pill is stuck in your throat
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
EQUALINE NAPROXEN SODIUM PM
diphenhydramine hydrochloride, naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-593 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 NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 15mm Flavor Imprint Code L264 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-593-58 1 in 1 CARTON 12/17/2019 04/30/2023 1 40 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41163-593-71 1 in 1 CARTON 03/25/2022 2 50 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208499 12/17/2019 Labeler - United Natural Foods, Inc. dba UNFI (943556183)
