Label: NAPROXEN SODIUM HEADACHE PAIN CAPLETS- naproxen sodium tablet, coated
NAPROXEN SODIUM BACK AND MUSCLE PAIN CAPLETS- naproxen sodium tablet, coated
- NDC Code(s): 43598-059-52, 43598-060-52
- Packager: Dr.Reddy's Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet/caplet)
- Purposes
- Uses
-
Warnings
SPL UNCLASSIFIED SECTION
Allergy alert: Naproxen sodium 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.
SPL UNCLASSIFIED SECTION
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you:
are age 60 or olderhave had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAID's (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
SPL UNCLASSIFIED SECTION
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, hear failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
OTC- ASK A DOCTOR SECTION
Ask a doctor before use if
the stomach bleeding warning applies to you
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 problems or serious side effects from taking pain relievers or fever reducers
OTC- DO NOT USE SECTION
Do not use
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
under a doctor's care for any serious condition
taking any other drug
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - STOP USE SECTION
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
fever gets worse or lasts more than 3 days
you have difficulty swallowing
it feels like the pill is stuck in your throat
redness or swelling is present in the painful area
any new symptoms appear
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-
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
Adults and children 12 years and older - take 1 tablet/caplet every 8 to 12 hours while symptoms last
- for the first dose you may take 2 tablets/caplets within the first hour
- do not exceed 2 tablets/caplets in any 8 to 12 hour period
- do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years - ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Headache Pain
- Back and Muscle Pain
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM HEADACHE PAIN CAPLETS
naproxen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-059 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 Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) hypromelloses (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 12mm Flavor Imprint Code R;273 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43598-059-52 225 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075168 08/05/2021 NAPROXEN SODIUM BACK AND MUSCLE PAIN CAPLETS
naproxen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-060 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 Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) hypromelloses (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 12mm Flavor Imprint Code R;273 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43598-060-52 225 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075168 08/05/2021 Labeler - Dr.Reddy's Laboratories Inc (802315887)