OTC Medication Information: ALL DAY PAIN RELIEF

ALL DAY PAIN RELIEF- naproxen sodium tablet, coated
WALGREENS

DRUG FACTS

Naproxen Sodium 220 mg

(naproxen 200 mg)(NSAID)*
*nonsteroidal anti-inflammatory drug

Pain reliever/Fever reducer

  • temporarily relieves minor aches and pains due to:

o minor pain of arthritis
o muscular aches
o backache
o menstrual cramps
o headache
o toothache
o the common cold

  • temporarily reduces fever

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.


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 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

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

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 a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

take with food or milk if stomach upset occurs

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

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

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 cablet every 8 to12 hours while symptoms last
for the first dose, you may take 2 caplets within the first hour
do not exceed 2 caplets in any 8-to 12-hour period
do not exceed 3 caplets in a 24-hour period


Children under 12 years:

ask a doctor

Other information

each caplet contains: sodium 20 mg store at 20-25ºC (68-77ºF).

Avoid high humidity and excessive heat above 40°C (104°F)

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

Questions or comments? call 1-877-290-4008

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ALL DAY PAIN RELIEF naproxen sodium tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9608
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
HYPROMELLOSES
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
MAGNESIUM STEARATE
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color blue Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 144
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9608-05 50 TABLET, COATED in 1 BOTTLE None
2 NDC:0363-9608-20 200 TABLET, COATED in 1 BOTTLE None
3 NDC:0363-9608-27 270 TABLET, COATED in 1 BOTTLE None
4 NDC:0363-9608-61 600 TABLET, COATED in 1 BOTTLE None
5 NDC:0363-9608-09 1 BOTTLE in 1 CARTON contains a BOTTLE
5 90 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (0363-9608-09)
6 NDC:0363-9608-90 90 TABLET, COATED in 1 BOTTLE None
7 NDC:0363-9608-42 1 BOTTLE in 1 CARTON contains a BOTTLE
7 24 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (0363-9608-42)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 06/26/2019
Labeler — WALGREENS (008965063)
Registrant — TIME CAP LABORATORIES, INC (037052099)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LTD 925822975 manufacture (0363-9608)

Revised: 03/2024 WALGREENS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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