Label: BACK AND MUSCLE PAIN- naproxen tablet, coated
- NDC Code(s): 0363-9609-01, 0363-9609-09, 0363-9609-42
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 15, 2024
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- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
asthma (wheezing)
blisters
facial swelling
hives
rash
shock
skin reddening
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 bad 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: NSAID's, except aspirin, increases 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
-
ASK DOCTOR
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
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
do not take more than directed
the smallest effective dose should be used
drink a full glass of water with each doseAdults and children 12 years and older:
take 1 tablet every 8 to12 hours while symptoms last
for first dose you may take 2 tablets with in the first hour
do not exceed 2 tablets in any 8-to 12-hour period
do not exceed 3 tablets in a 24-hour period
Children under 12 years:ask a doctor
- Other information
- INACTIVE INGREDIENTS
- QUESTIONS
- 24 CT
- 100 CT
- 90 CT
-
INGREDIENTS AND APPEARANCE
BACK AND MUSCLE PAIN
naproxen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9609 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code 141 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9609-42 24 in 1 BOTTLE; Type 0: Not a Combination Product 06/05/2019 2 NDC:0363-9609-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/03/2019 3 NDC:0363-9609-09 1 in 1 CARTON 06/26/2021 3 90 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 ANDA090545 06/03/2019 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES, INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LTD 925822975 manufacture(0363-9609)