Label: NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE tablet
- NDC Code(s): 21130-814-05
- Packager: SAFEWAY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2023
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- Official Label (Printer Friendly)
- Active Ingredients (in each caplet)
- Purpose
- Uses
- Allergy alert
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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 steriod 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
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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
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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
- When using this product
-
Stop use and ask a doctor if
■ you expereince 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
■ you have difficulty swallowing
■ it feels like the pill is stuck in your throat
- If pregnant or breast-feeding
- Keep out of the reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PDP
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE
naproxen sodium diphenhydramine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-814 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color blue Score no score Shape CAPSULE Size 15mm Flavor Imprint Code G;17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-814-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213663 06/30/2023 Labeler - SAFEWAY (009137209)