Valumeds All Day Pain Relief

Valumeds All Day Pain Relief
SPL v2
SPL
SPL Set ID 2a8df549-613b-4fdb-8251-e6d63078e103
Route
ORAL
Published
Effective Date 2018-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 2 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 144 Shape: oval Color: blue Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2018-04-11

Description

Drug Facts

Purpose

Pain reliever/ fever reducer


Medication Information

Warnings and Precautions

Warnings

Purpose

Pain reliever/ fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrul cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away. (1-800-222-1222)

Section 53414-9

If pregnant or breast feeding, ask a health profession 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 complication during the delivery.

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 every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within 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

Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after surgery
Other Information
  • each tablet contains: sodium 20 mg
  • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Inactive Ingredients

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

Questions Or Comments?

1-888-333-9792

When Using This Product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Ask A Doctor Before Use If
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems,such as a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma
Stop Use and Ask A Doctor If
  • you experience any of following sign of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feel like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
Active Ingredient (in Each Tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor 's care for any serious conditions
  • taking any other drug
Principal Display Panel 15 Count Bottle Carton

VALUMEDS™

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient

in ALEVE®*

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)


Structured Label Content

Uses
  • temporarily relieves minor aches and pain due to :
  • backache
  • headache
  • menstrul cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away. (1-800-222-1222)

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health profession 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 complication during the delivery.

Purpose

Pain reliever/ fever reducer

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 every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within 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

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after surgery
Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Ask A Doctor Before Use If (Ask a doctor before use if)
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems,such as a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience any of following sign of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feel like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • under a doctor 's care for any serious conditions
  • taking any other drug
Principal Display Panel 15 Count Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 COUNT BOTTLE CARTON)

VALUMEDS™

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient

in ALEVE®*

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)


Advanced Ingredient Data


Raw Label Data

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